Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded
Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Any medical condition for which prednisone (corticosteroid) is contraindicated
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the study chair or study co-chairs for uncertainty in this regard
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
Patient has any other medical, psychiatric, or social condition, including substance abuse, that in the opinion of the investigator would preclude compliance with the requirements of this study
A serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy
Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment
Any malabsorption problem that, in the investigator's opinion, would prevent adequate absorption of the study drug
Any other medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities.
Patients who have any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at risk are not eligible
Presence of concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia.
Patient receiving concomitant therapy, which in the opinion of the Investigator is considered relevant for the evaluation of the efficacy or safety of the trial drug.
Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
Participants must, in the opinion of the investigator, be capable of complying with the protocol
Patients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Any other active malignancy other than melanoma that, in the opinion of the investigator, would interfere with study participation (for treatment phase)
Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
Active infection or an unexplained fever > 38.5 degrees Celsius (C) during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled), which in the investigator’s opinion might compromise the patient’s participation in the trial or affect the study outcome
Has a medical condition that requires immunosuppression
History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
Life-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ASTX727, or compromise completion of the study or integrity of the study outcomes.
Any uncontrolled medical condition (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment or confound interpretation of study assessments.
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study.
Patients that have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are excluded
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
Presence of an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing, which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolled
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the Subject in this study.
Expected survival of ? 12 weeks, in the opinion of the investigator.
Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the subject at risk.
Medical or psychiatric illnesses that, in the investigator's opinion, may impact the safety of the subject or the objectives of the study.
History of other significant cardiovascular diseases or vascular diseases within the last 6 months prior to randomization that, in the investigator's opinion, may pose a risk to the patient on VEGF inhibitor therapy.
Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
Any other condition which the Investigator believes would make participation in the study not acceptable
Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result.
Any other condition which, in the opinion of the investigator, would preclude participation in this trial
High likelihood of protocol non-compliance (in opinion of investigator)
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Any significant medical illnesses or infection that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are not eligible for participation
Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient (see Section 4.4-4.10).
Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures
Underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events (AEs).
Any clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Any serious medical condition that interferes with adherence to study procedures.
Patient must not have a co-morbid condition(s) that, in the opinion of the investigator, prevent safe treatment
Any history of a medical condition or a concomitant medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study
Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol
Any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drug
Any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient
Has any other reason(s) for the investigator to consider that the subject should not participate in the study.
Uncontrolled or progressive systemic disease or other concurrent condition which in the Investigator’s opinion makes HD-MTX an undesirable treatment option for the patient or would jeopardize compliance
History or presence of a medical condition or disease or substance abuse that in the investigator's assessment would place the patient at an unacceptable risk for study participation
Any other concomitant serious illness or organ system dysfunction in opinion of Investigator would either compromise subject safety or interfere with test drug safety evaluation
Any other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Any medical condition or laboratory abnormalities, which – in the opinion of the investigator – places the subject at unacceptable risk, or confounds the ability to interpret data if he/she were to participate in the study
•A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
Any condition, in the opinion of the investigator, that compromises compliance with study requirements
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
Any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drug
Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/principal investigator (PI)
Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug
Any screening laboratory, electrocardiogram (ECG), or other findings that, in the opinion of the investigator or the sponsor, indicate an unacceptable risk for the subject's participation in the study.
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
Subject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.
Other unspecified reasons that, in the opinion of the investigator, make the patient unsuitable for enrollment
Significant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient
Active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
Any serious medical condition that interferes with adherence to study procedures.
Any other medical condition that in the investigator’s opinion would not make the patient a good candidate for the study
PHASE II EXCLUSION CRITERIA: Any other medical condition that in the investigator’s opinion would not make the patient a good candidate for the study
Any significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.
Subject has any condition that confounds the ability to interpret data from the study.
Any other factors, including psychiatric or social, that in the opinion of the treating physician makes the patient an inappropriate candidate for a study
Any electrocardiogram (ECG) abnormality, which in the opinion of the Investigator would preclude safe participation in the study.
Serious non-malignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
Any medical condition that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of study treatment
Subject is known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder); subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Women with skin conditions such as psoriasis, fungal infections, keloids etc., or tattoos and/or piercings, which in the opinion of the Investigator, would interfere with absorption of the IP.
Women with a concurrent illness, disease or condition that, in the opinion of the Investigator, would limit their compliance with study requirements or place them at additional risk.
Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study
Other medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent.
Serious cardiopulmonary medical condition
Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol
Any other medical or social condition that, in the opinion of the investigator, would not permit the patient to complete the study or sign informed consent
PROCUREMENT EXCLUSION CRITERIA: Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation
Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation
Any condition that in the opinion of the investigator, would preclude participation in this study
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Presence of any severe or uncontrolled concurrent medical condition felt in the opinion of the investigator to increase the risk of serious toxicity from the study therapy
Underlying medical condition that, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events;
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results
Underlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
Participants must in the opinion of the investigator be capable of complying with this protocol
Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders that could compromise the patient's safety or the study data integrity.
Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.
Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any other medical condition that in the Investigator’s opinion would not make the patient a good candidate for the study
In the opinion of the treating investigator, the patient must be a candidate to receive gemcitabine/cisplatin treatment
Serious co-morbid medical conditions, or a clinically significant laboratory finding(s) or any finding(s) on history and/or examination that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk;
Have other concurrent severe and/or uncontrolled medical condition that would, in the site Investigator's judgment contraindicate the patient's participation in the clinical study
History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease or coronary artery disease).
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any significant psychiatric disease, medical or other condition, which in the opinion of the principal investigator could prevent adequate informed consent or compromise participation in the clinical trial
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient; subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator’s judgment
Any medical conditions that, in the opinion of the investigator, would preclude use of AGEN1884, including AGEN1884 hypersensitivity.
The patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Any condition that confounds the ability to interpret data from the study
Subject requires any medical intervention(s) or has any other condition(s) that, in the Investigator’s opinion, will 1) make the administration of PROSTVAC or ipilimumab hazardous, 2) obscure the interpretation of adverse events (AEs), 3) compromise adherence with study requirements, or 4) otherwise compromise the study’s objectives
Any malabsorption condition
Any condition which makes the subject unsuitable for trial participation
Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study’s objectives
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any condition or illness that, in the investigator’s opinion, would place the subject at unacceptable risk if he/she were to participate
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Uncontrolled cystitis, significant bladder pain or spasms, or gross hematuria that in the opinion of the treating investigator, should preclude study entry
Clinical judgment by the investigator that the patient should not participate in the study
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any other pathology or condition which the principal investigator may deem to negatively impact treatment safety
Patients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:\r\n* Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years\r\n* Any condition, medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up, or compliance with any aspect of the study
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of study agents hazardous or obscure the interpretation of adverse events (AEs)
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.
Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives
Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject’s safety or put the study outcomes at undue risk
Patients whose comorbid medical condition, in the investigator’s opinion, would make participation in this trial and adherence to the protocol guidelines difficult should be excluded
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Chronic or acute renal or hepatic disorder or any other condition, medical or psychological that, in the opinion of the investigator, could jeopardize the subject’s safe participation
Any subject who, in the opinion of the principal investigator (PI) is at risk for thromboembolic events
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the patient’s risk by participating in this study)
Any other serious medical condition which in the Investigator's opinion would preclude safe participation in the study.
Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study.
Patients that have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are excluded
Patients with a \currently active\ second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretation
Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
Patients must NOT have any concurrent medical condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy; patients with a primary immunodeficiency/ bone marrow failure syndrome are excluded from this trial
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease, within the last 6 months that, in the opinion of the investigator, would adversely affect his/her participation in the study.
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Patients with rapidly progressing disease in the opinion of the principal investigator
Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
Presence of any concurrent illness or condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/principal investigator (PI)
Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment
No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
Any condition or set of circumstances that the principal investigator (PI) or lead associate investigator (LAI) interprets as creating undue risk to the patient by participating on this study or would make the patient unlikely to comply with the study
Any condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individual
Known history of allergy or intolerance which, in the opinion of the investigator, was an unacceptable adverse reaction attributed by the investigator to any prior anti-neoplastic therapy specifically targeting T-cell costimulation or immune checkpoint pathways – i.e. nivolumab (Opdivo), pembrolizumab (Keytruda), atezolizumab (Tecentriq), ipilimumab (Yervoy), etc.
Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements.
Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy
Clinically relevant diseases (for example, inflammatory bowel disease) and /or uncontrolled medical conditions, which, in the opinion of the investigator, might impair the subject’s tolerance or ability to participate in the trial.
Patient with concurrent severe and/or uncontrolled medical conditions that, in the opinion of the investigator, may impair participation in the study or the evaluation of safety and/or efficacy
Subject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk for such interference (for example, short bowel syndrome or inflammatory bowel disease).
The recipient has another medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery in which the opinion of the principal investigator would place the recipient at unacceptable risk
In the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatment
Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, ? Grade 3 thromboembolic event in the last 6 months)
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Other medical or psychiatric illness or organ dysfunction, which in the opinion of the investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Clinically relevant diseases (for example, inflammatory bowel disease) and/or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject’s tolerance or ability to participate in the trial
Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his/her designee, would prevent adequate informed consent.
Any other condition that in the investigator’s judgement would significantly increase the risks of participation.
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.
Any clinically significant uncontrolled condition that may increase the risk to the study patient or that the Investigator considers places the patient at unacceptable risk
Any condition which, in the opinion of the investigator, would preclude participation in this trial
Clinically relevant diseases (for example, inflammatory bowel disease) and / or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject’s tolerance or ability to participate in the trial.
Any severe, uncontrolled disease or condition which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or impact the subject's participation in the study
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
Significant medical conditions (including widely disseminated metastatic disease) or laboratory results that, in the opinion of the investigator, indicate an increased vulnerability to study drugs and procedures.
Presence of a concomitant medical condition that (in the judgement of the investigator) interferes with the ability of the subject to participate in the study.
The presence of a medical or psychiatric condition that, in the opinion of the principal investigator, makes the patient inappropriate for inclusion in this study
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.
Any illness, medical condition or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of lenalidomide, or put the study outcomes at undue risk
Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
Any additional condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive the study drugs
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator
Any coexistent medical condition interfering with drug absorption
History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Cancer-Related Exclusion Criteria
Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of azacitidine that in the opinion of the investigator would adversely affect his/her participating in this study.
Patients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Participants must, in the opinion of the Investigator, be capable of complying with the requirements of this protocol including self-administration of study treatment
Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Any prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study
Any co-morbid medical condition that may put the patient at significant risk for toxicity
Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Subjects with life-threatening illnesses other than MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, or put the study outcomes at risk
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial; places the patient at undue risk; or complicates the interpretation of the data, in the opinion of the investigator or medical monitor
In the opinion of the Investigator would benefit from continued treatment.
Medical condition including but not limited to ongoing or active infection or connective tissue disease (e.g. systemic sclerosis or other collagen vascular diseases) that would, in the opinion of the treating physician, make this protocol unreasonably hazardous to the patient
Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.
Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other condition which, in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Subjects must NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; subjects with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trial
Any medical intervention or other condition which, in the opinion of the principal investigator, could compromise adherence with study requirements or otherwise compromise the study’s objectives
Medical or psychological conditions present within 30 days prior to enrollment that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)
History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient’s safety or compliance on trial
History of severe autoimmune disease that in the opinion of the investigator would interfere with patient safety or compliance on trial
Any condition or history of illness or surgery that in the opinion of the investigator might affect the conduct and results of the study or pose additional risks to the subject (e.g., cardiac or respiratory disease precluding general anesthesia; anticoagulant treatment which cannot be temporarily withdrawn for the procedure).
Life expectancy < 6 months due to any condition other than BOS that, in the opinion of the investigator, is likely to result in the death of the patient
Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Subjects with any concomitant disease or condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated.
Any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting.
Patient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant
A serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapy
Pt may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant
Any other cardiac condition that, in the opinion of the investigator, could pose an additional risk for participation in the study (example, pericardial effusion or restrictive cardiomyopathy).
Any other medical or psychiatric disorders, or social situation, that would, in the investigator's opinion, place the subject at unacceptable risk if he/she participates in the study.
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results.
Subject has any condition including the presence of laboratory abnormalities which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
Subject has any condition that confounds the ability to interpret data from the study.
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe or ineligible for protocol procedures
Any medical conditions that, in the investigator’s opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study, including:
Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Has any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
Subjects must NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; subjects with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trial
Subject has any condition which makes the subject unsuitable for study participation.
Subjects with medical condition that could adversely impact the study participation or assessments.
Any other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study
Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Any mental or physical condition, in the opinion of the PI (or PI designee), which could interfere with the ability of the subject (or the only parent or legal guardian available to care for the subject) to understand or adhere to the requirements of the study
Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
Normal organ function since eligibility screening, and no new clinical or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any severe, uncontrolled disease or condition, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or impact the subject's participation in the study
Normal organ function since eligibility screening, and no new clinical or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety
Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study.
Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
Any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase subject’s risk, interfere with protocol adherence, or affect a subject’s ability to give informed consent
The presence of any medical condition that the Investigator deems incompatible with participation in the trial
Any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease, that, in the opinion of the study investigator, would make the patient a poor candidate for the study
Has any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined) that, in the opinion of the principal investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results
Any other pathology or condition that the principal investigator deems to negatively impact treatment safety
Osseous metastatic disease with unacceptable risk of impending fracture due to study assessments, in the opinion of the investigator
Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs: e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies.
Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, including any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.
Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient’s safety
Patients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent rashes or diarrhea
Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study
Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the trial, and/or compromise the objectives of the trial
Any other health condition that would preclude participation in the study in the judgment of the principal investigator
All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment
Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapy
Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study
Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of LDAC that in the opinion of the investigator would adversely affect his/her participating in this study.
Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug
Any concurrent condition which in the investigator’s opinion makes it undesirable for the subject to participate in this trial or which would jeopardize compliance with the protocol
Any other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the study
Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment
Any prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study
Any life threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any malabsorption condition
Subjects with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol
Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled
Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy.
Serious active infection at the time of enrolment, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment
Patients must not have any significant infections or medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate NU-0129
Comorbid condition(s) which, in the opinion of the attending physician and/or MSK Cancer Center (CC) principal investigator, will preclude stem cell mobilization and/or high-dose therapy with autologous stem cell rescue
No other condition which, in the opinion of the Investigator, would preclude participation in this trial
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
In the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
A concomitant medical condition that in the opinion of the treating physician would pose unreasonable additional risk to therapeutic injection of ONCOS-102.
Any illness, medical condition or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of venetoclax and lenalidomide, or put the study outcomes at undue risk
Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any other medical or surgical condition or disease that, in the judgment of the treating physician, renders subject ineligible for high dose interleukin-2 therapy
Presence of underlying medical condition that in the opinion of the investigator or sponsor could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of DS-8273A and nivolumab in treated subjects
Subjects must not have a history of other serious underlying medical or psychiatric condition that, in the opinion of the investigator, would impair the ability to receive, tolerate and or comply with the planned treatment and follow-up
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
Any clinically significant medical disease or condition that, in the treating investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Any condition which, in the opinion of the investigator, would preclude participation in this trial
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation procedures or completion.
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment
Chronic alcohol or drug abuse or any condition that, in the Investigator's opinion, makes him/her an unreliable trial subject, unlikely to complete the trial, or unable to comply with the protocol procedures.
Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Have a serious preexisting medical condition that, in the opinion of the investigator would preclude participation in the study (for example a GI disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndrome) or that would result in a life expectancy of less than 1 year
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigators’ opinion, could compromise the subject’s safety or put the study outcomes at undue risk
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib, or put the study outcomes at undue risk
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator
Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
Patients are excluded for any underlying medical or psychiatric condition which, in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
Any condition, including laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator, would prohibit administration of planned chemotherapeutic intervention, places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study
Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
Any life-threatening illness, known autoimmune disease, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any concomitant disease or condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk
Other known other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult
No serious disease or condition that, in the opinion of the investigator, would compromise the patient’s ability to participate in the study
Any condition that in the opinion of the investigator, would preclude participation in this study
Clinical judgment by the investigator that the patient should not participate in the study
Patients positive for hepatitis C are permitted if controlled with medication, in the opinion of the investigator
Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
Active infection requiring antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy
Underlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events
Serious underlying medical conditions that, per the Investigator's discretion, could impair the ability of the patient to participate in the trial
Any condition or organ toxicity deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocol
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
Eligible for therapy for the lymphoid malignancy which has a high likelihood of a curative result in the opinion of the investigator
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Current evidence of any of the following:\r\n* Uncontrolled hypertension \r\n* Gastrointestinal disorder affecting absorption\r\n* Active infection (e.g. human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated\r\n* Any condition that in the opinion of the investigator, would preclude participation in this study
Any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject’s participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subject
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events
Either a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the study
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, may compromise the subject's ability to participate in this study
Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs): e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies
Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment
Any other condition that, according to the investigator, may forbid the administration of the idarubicin + cytarabine regimen
Other serious, ongoing, non-malignant disease or infection that would in the opinion of the site investigator compromise other protocol objectives
hepatic, renal neurological or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives.
Any medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject\r\n* Examples of such conditions include:\r\n** Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder\r\n** Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent\r\n** Active infection that requires parenteral anti-microbial or anti-parasitic treatment
Patients with a significant psychiatric disease, who in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe will be excluded
Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient; subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests, or chest-X-ray and according to the investigator’s judgment
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
In the investigator’s judgment, any comorbid disease or condition that would place the patient at undue risk and preclude safe use of radioembolization or TAS-102
Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:\r\n* Any uncontrolled infection\r\n* Cardiac failure NYHA (New York Heart Association) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Bone marrow dysplasia\r\n* Known allergy to any of the compounds under investigation\r\n* Unmanageable fecal incontinence
Any medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained are not eligible
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
Any condition or organ toxicity that is deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocol
No uncontrolled, inter-current or recent illness that in the investigator’s opinion precludes participation in the study, including those undergoing therapy for a separate invasive malignancy
Serious illness or medical condition that could affect the safety or tolerability of study treatments
Any condition or reason that in the opinion of the investigator, interferes with the ability of the patient to participate in the trial
Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible
Any condition which, in the opinion of the investigator, would preclude participation in this trial
Any other current or previous malignancy within the past three years that, in the opinion of the Principal Investigator, will interfere with study-specific objectives.
Any medical condition, which in the investigator's opinion, could compromise the patient's safety
Any other conditions or circumstances that would, in the opinion of the investigator, make the patient unsuitable for participation in the study
Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the patient in this study
Any malabsorption condition.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Current evidence of any of the following:\r\n* Uncontrolled hypertension\r\n* Gastrointestinal disorder affecting absorption\r\n* Active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)\r\n* Any chronic medical condition requiring a dose of corticosteroid higher than 10 mg prednisone/prednisolone once daily\r\n* Any condition that, in the opinion of the site investigator, would preclude participation in this study\r\n* Moderate or severe hepatic impairment (Child Pugh class B or C)
Have any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical trial data interpretation
Any severe concurrent disease, infection or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or interferes with the patient's ability to participate in the study requirements
Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization
Any medical or other condition that, in the opinion of the investigator, would preclude the subject's participation in a clinical study
Subjects may not receive ABBV-399 in combination with erlotinib or nivolumab if they have any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities from the combination.
Any electrocardiogram (ECG) abnormality that in the opinion of the principal investigator would preclude safe participation in the study
Any condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable risk
Has any other medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient’s successful completion of the clinical trial
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or the patient’s ability to give informed consent
NONCOMPLIANCE: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Any mental or physical condition, in the opinion of the Principal Investigator (PI) (or PI designee), which could interfere with the ability of the subject (or the only parent or legal guardian available to care for the subject) to understand or adhere to the requirements of the study
Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent
Patient, in the opinion of the investigator, is likely to be poorly compliant
Any other medical intervention or condition, which, in the opinion of the PI or treating physician, could compromise patient safety or adherence with the study requirements over the primary 3-6 month treatment period
Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of enzalutamide, or put the study outcomes at undue risk
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
Life expectancy of ? 2 months. 6. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include: • Unstable cardiovascular conditions at Baseline including but not limited to:
A co-morbid condition that, in the Investigator's opinion, renders the subject at high risk for treatment complications.
The recipient has a medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the principal investigator would place the recipient at unacceptable risk
Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.
Have a psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the primary physician would place the patient at an unacceptable risk from transplant
Serious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the patient's ability to receive study treatment.
Unstable coronary artery disease or other medical condition (such as type 1 diabetes) that, in the Investigator's opinion, might increase the risk to the patient
In the investigator’s opinion, the patient has the ability to communicate satisfactorily with the investigator, to participate fully in the study, and comply with all its requirements
Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment
Any medical or psychological condition or situation deemed by the principal investigator (PI) to put the patient at increased risk of complications or noncompliance
Any other medical condition for which the treating physicians deem might lead to unacceptable toxicity or morbidity for that treatment plan for the patient e.g., allergy to a component of therapy or a medical condition that might be aggravated by the therapy and increases potential risk of toxicity in the opinion of the treating physicians
History of psychiatric disorder or any other condition which may compromise compliance with transplant protocol or expose patient to unnecessary risk as determined by principal investigator or lead associate investigator
Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any concurrent or past medical condition that, in the opinion of the investigator, would exclude the subject from participation
Requirement for treatment in the opinion of the investigator.
Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.
No condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Life expectancy is not severely limited by concomitant illness in the opinion of the treating investigator
Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient
Patient has any condition or laboratory abnormality which, in the opinion of the investigator, would pose additional risk in administering the study drug to the patient
Has a concomitant medical condition that would in the opinion of the Investigator increase the risk of toxicity.
Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study’s endpoints
Patient does NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; patients with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trial
Any malabsorption condition
Significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or autoimmune conditions that in the opinion of the investigator places the subject at an unacceptable risk as participant in this trial
Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
Underlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events: (AE's) e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies
The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance
Any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Any condition that is unstable and could jeopardize the subject's participation in the study.
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements
Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Patients with a medical condition or social situation that at the discretion of the Principal Investigator (PI) would preclude them from completion of the trial
Patients unable to receive cisplatin in the opinion of the medical oncologist
Active second malignancy that in the opinion of the principal investigator (PI) may interfere with or be adversely affected by this treatment
Either a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the study
Any other pathology or condition where the principle investigator may deem to negatively impact treatment safety
Patients with medical conditions which, in the opinion of the investigators, would pose undue risk to the patient
No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study
Any other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Patients who exhibit any significant concurrent, uncontrolled medical or psychiatric condition that in the opinion of the investigator would compromise the patient's ability to tolerate this treatment are NOT eligible for participation
Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent (Turnstile I)
Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated (Turnstile II)
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study
Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety
Uncontrolled significant intercurrent illness that would preclude the patient from study participation per investigator assessment
Any condition which in the Investigator’s opinion deems the subject an unsuitable candidate to receive study drug
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
A serious uncontrolled medical disorder that is in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
Other condition(s) that in the opinion of the investigator might compromise the objectives of the study
Any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Patients with other medical conditions or concomitant medications that in the opinion of the principal investigator may interfere with the therapeutic treatment.
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug
Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated (Turnstile II)
Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of Adverse Events (AEs): e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies.
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Serious nonmalignant disease which, in the opinion of the investigator would compromise protocol objectives
Medical or psychological conditions that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)
Patients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Patients with other significant disease or disorders that, in the investigator's opinion, would exclude the patient from the study
History of venous or arterial thromboembolism, unless:\r\n* Line-related thrombosis without embolus occurring >= 1 year prior to screening\r\n* Complications resulting from atherosclerotic coronary artery disease, peripheral vascular disease, or cerebrovascular disease (including infarction) are not considered exclusion criteria unless in the opinion of the principal investigator or lead associate investigator their clinical consequences in a particular subject places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study
Any condition, including the presence of laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study
Patients has any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Any condition which, in the opinion of the investigator, would preclude participation in this trial
Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.
Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Significant co-morbid condition or disease which in the judgment of the principal investigator would place the patient at undue risk or interfere with the study
Medical illness unrelated to Hodgkin lymphoma, which, in the opinion of the attending physician and/or Memorial Sloan Kettering (MSK) principal investigator, makes participation in this study inappropriate
Patients with any significant medical illnesses that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
In the judgment of the investigator, participation in the protocol offers acceptable risk/benefit ratio when considering current NF2 disease status, medical condition, and the potential benefits of and risks of surgery or irradiation
No other medical and or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptable risk from this regimen
Infection or any other severe systemic disease or medical or surgical condition deemed significant by the principal investigator
Subjects who have other conditions which in the opinion of the investigator contraindicate the receipt of HSV1716 or indicate subject’s inability to follow protocol requirements
Any co morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
Patients should have uncontrolled intercurrent illness, which in the opinion of the attending medical oncologist, would render the patient unsuitable for the study (i.e., preclude safe administration of the prescribed chemotherapy treatment).
Patient who is otherwise considered unsuitable for transplant at the discretion of the principal investigator
Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
Patients who in the opinion of the principal investigator are poor psychiatric or medical risks are not eligible
Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Has any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
Intolerance to the investigational product or its excipients, or any condition that would significantly impair and/or prohibit the patient's participation in the study, as per the Investigator's judgment.
Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject. Additional Exclusion Criteria for Cohort 1:
Any other condition that might place the patient at undue risk.
Any condition which in the investigator’s opinion deems the participant ineligible
Intensive care unit (ICU) care, life expectancy of less than 28 days, ongoing or unresolved hepatic sinusoidal obstruction syndrome, unstable hemodynamics, or evidence of current or previous clinically significant disease, medical condition or finding (including vital signs and ECG) that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
Clinically significant abnormalities or co-morbidities, other than HCV infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen
Any other diseases that, in the opinion of the investigator and Sponsor's medical monitor would pose a risk to the subject safety
All other significant diseases, which in the opinion of the investigator, may impair the subject’s tolerance of trial treatment
Any other clinical condition, psychiatric condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable or to comply with follow-up visits
No other illness that in the opinion of the investigator would exclude the subject from participating in the study
Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol
any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.
Peripheral oedema at Screening that in the opinion of the Prinicpal Investigator (PI) or designee might prevent adequate absorption of subcutaneously administered CPHPC
Presence of any co-morbid or an uncontrolled medical condition (e.g. diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a patient
Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
Presence of a comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol
Any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
Subject has any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
Has a serious illness or medical condition(s) that would affect safety or tolerability of the study treatments
Patients who have any other life threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the study drug
Any condition that is unstable and could jeopardize the patient's participation in the study.
Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
No underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Patients with significant concurrent, uncontrolled medical condition including, but not limited to, cardiovascular, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient, are NOT eligible
Patients with life-threatening condition or complication other than their basic condition
Any condition that is unstable or which could jeopardize the safety of the patient (please refer to the Investigator Brochure and product labeling safety sections).
Any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
Patients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:\r\n* Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years\r\n* Any condition- medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study
Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the subject's risk while participating in this study
Any new or uncontrolled condition that could make the patient unsuitable for participation
Patients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risks
Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results;
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible.
224 History or evidence of any other clinically-relevant concurrent disorder, condition or disease (eg, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia requiring therapy at time of screening) with the exception of those outlined above that, in the opinion of the investigator or Amgen medical monitor, if consulted, would not pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Serious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment
Subjects who, in the opinion of the Investigator, have a high probability of death within 3 months of randomization due to a disease process other than the CRBSI/CLABSI
Has any history or medical condition, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
Comorbid disease or a medical or psychiatric condition that would impair the ability of the patient to receive or comply with the study protocol.
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria.
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
History or presence of an ECG that, in the investigator's opinion, is clinically meaningful as per protocol-defined criteria.
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject’s ALL
A life threatening illness, medical condition or organ system dysfunction which, in the investigators’ opinion, could compromise the subject’s safety or interfere with the absorption or metabolism of pembrolizumab
History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
Any condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained
In the investigator's judgment, any other condition that jeopardizes the patient's participation in the treatment phase
Any condition that may, in the opinion of the investigator, compromise the safety of the patient
Any condition medical or psychosocial that in the opinion of the investigator would hinder compliance
Any other condition that would, in the opinion of the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk
Concurrent medical condition that precludes safe participation in this study
Serious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment.
Any condition that confounds the ability to interpret data from the study
Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study and treatment plan.
History of previous malignancy that in the principal investigator (PI)’s opinion has a reasonable chance of recurrence during the study period or otherwise confounding this clinical trial
Any other illness or condition that in the investigator’s opinion would adversely affect the safety of checkpoint inhibitor therapy
Any other condition that, in the opinion of the Investigator, would impair the patient’s ability to comply with study procedures
Any condition that would make the patient, in the opinion of the investigator, unsuitable for the study (eg, would place a patient at risk or compromise the quality of the data
RENAL & BLADDER: Any condition that in the opinion of the investigator, would preclude participation in this study
Any serious medical condition that interferes with adherence to study procedures.
Psychiatric, other medical illness or other condition that in the opinion of the principal investigator (PI) prevents compliance with study procedures or ability to provide valid informed consent.
Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events.
Any serious medical condition that, in the investigator opinion, places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form. Examples include but are not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, active infection requiring treatment with intravenous (IV) antibiotics, antiviral or antifungal agents, active hemorrhage, or psychiatric illness in the investigator’s opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form.
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL with a life expectancy < 2 years.
THE PATIENT IS INELIGIBLE TO PARTICIPATE IN PART 2 IF ANY OF THE FOLLOWING OCCUR: Part 1 data contradict clinical judgment. The investigator should discuss with the principal investigator (PI) and use the best discretion.
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
In the opinion of the investigator, the participant is an unsuitable candidate for this study
Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Patients who have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatment
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Current or prior disease or treatment that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
History of intratumoral or peritumoral hemorrhage if deemed significant by the treating investigator; if there are questions, the treating investigator should contact the study overall principal investigator (P.I.), Eudocia Quant Lee, medical doctor (MD), at 617-632-2166 or eqlee@partners.org
Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for the study
Active infection or other medical condition that would make prednisone use contraindicated
Any condition that in the opinion of the investigator, would preclude participation in this study
Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of the study drugs hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug. (i.e., any significant medical illness or abnormal laboratory finding that would increase the patient’s risk by participating in this study)
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
Patients for whom it is not in the best interest to participate in the study, in the opinion of the treating investigator
Any other therapy or serious medical condition, as specified in the protocol, or abnormality in clinical laboratory tests that, in the investigator's judgement, precludes the participant's safe participation in and completion of the study
Subjects with a life-threatening illness, medical condition or organ system dysfunction, or other reasons which, in the investigator’s opinion, could compromise the subject’s safety, interfere with or compromise the integrity of the study outcomes including incomplete recovery from the acute effects from any prior anti-neoplastic therapy
ARM A: Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the study
ARM B: Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the study
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the study participant or the quality of the study data
Any condition or medical problem in addition to the underlying malignancy and organ dysfunction that the investigator feels would pose unacceptable risk
Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial
Patients currently receiving any medication known to induce central serous chorioretinopathy which in the opinion of the principal investigator, would make the administration of study drug hazardous
Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events
A serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapy
Patient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant
Current life-threatening illness, medical condition, or organ system dysfunction, which, in the investigator’s opinion, could compromise the patient’s safety, or put the study at risk
Patients with malabsorption or any other condition that in the opinion of the principal investigator could cause difficulty in absorption of drug
Any concurrent or past medical condition that, in the opinion of the Investigator, would exclude the subject from participation or any psychosocial conditions that would hinder study compliance or follow-up, at the discretion of the Investigator
Any condition or behavior that in the judgment of the investigator, would compromise the patient’s ability to participate in the study and/or comply with study procedures
Any underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of adverse events (AEs)
Any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures
Any underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of adverse events (AEs)
Subjects must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the subjects to receive protocol treatment
Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Any physical or mental condition that, in the opinion of the PI, would cause the risk/benefit ratio of participation to be unacceptable
Any other reason the investigator considers the patient should not participate in the\n             study
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of CYT107 hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients with a baseline of frequent diarrhea (e.g. irritable bowel syndrome) are not eligible
Clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or the patient's ability to give informed consent
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any concurrent health condition that in the view of the treating physician would pose excessive risk to the patient if enrolled in the study
No presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 months
Any medical condition which, in the investigator's opinion, could compromise the patient's safety
Patients with significant medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Any condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable risk
Subject has any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications
Any medical condition that would compromise the subject’s ability to safely participate in the study
Other condition(s) that in the opinion of the investigator might compromise the objectives of the study or increase patient risk
Patients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent rashes or diarrhea
Active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the patient unsafe to proceed with the study
No gastro-intestinal condition, that in the opinion of the treating physician or the principal investigator significantly limits oral absorption
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of INCB024360 hazardous or obscure the interpretation of adverse events
Subjects with any concurrent condition that, in the investigator’s opinion, would jeopardize the safety of the subject or compliance with the protocol
Medical conditions which, in the opinion of the investigators, would jeopardize the patient or the integrity of the data obtained
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Any condition which in the investigator’s opinion makes the subject unsuitable for study participation
Any serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or compliance of the trial
Previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study
Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment
Any medical intervention or other condition which, in the opinion of the principal investigator could compromise adherence with study requirements or otherwise compromise the study's objectives
Any condition which the investigator's opinion deems the patient ineligible
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy
Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics
Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated
Any medical or psychiatric illness, which in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment or limit compliance with study requirements
Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated
Patients must not have a history of any condition (social or medical) that, in the opinion of the investigator, might interfere with the patient’s ability to comply with the protocol or pose additional or unacceptable risk to the patient
Patients with other significant diseases or disorders that, in the investigator’s opinion, would exclude them from the study
Serious psychiatric condition or addictive disorder
Patients may be excluded at the discretion of the principal investigator (PI) or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk
Underlying medical condition (e.g., a condition associated with diarrhea) that, in the investigator's opinion, would make the administration of either study drug or both study drugs hazardous to the subject or obscure the interpretation of toxicity determination or adverse events
Underlying medical condition (eg, a condition associated with diarrhea) that, in the Investigator’s opinion, would make the administration of either study drug or both study drugs hazardous to the subject or obscure the interpretation of toxicity determination or adverse events
Any condition (psychological, physical or use/abuse of substances) which, in the opinion of the principal investigator (PI) or a sub-investigator (sub-I), would possibly endanger the subject during their participation in the study, or allow for non-compliance with the investigational drug and treatment under study
Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment
Patients must not have any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug
Any other concurrent illness which in investigator’s opinion puts the patient at excessive risk of treatment related toxicities
Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment
Any other significant disease or other clinical findings which in the opinion of the investigator would prevent study entry
Subject has any condition which makes the subject unsuitable for study participation.
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the patient unsuitable for trial participation
Medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.
Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study
Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
Subject has any condition that confounds the ability to interpret data from the study.
Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders).
Subject with any other condition which in the opinion of the investigator would preclude participation in the study.
History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful
Inability to comply with protocol and /or not willing or not available for follow-up assessments or any condition which in the investigator's opinion makes the patient unsuitable for the study participation
c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
Any other medical condition or laboratory evaluation that, in the treating physician’s or principal investigator’s opinion, makes the patient unsuitable to participate in this clinical trial
Patients may not have any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial
have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
Subject has any condition that confounds the ability to interpret data from the study.
Subject with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise subject safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of ASTX660.
The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications
The patient has any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities.
Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study
Co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgment
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study.
Any condition that confounds the ability to interpret data from the study
Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.
Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.
Concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
Any other condition which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment, the safety of the individual subject or the outcome of the trial. (including but not limited to: history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, suicidal attempt or ideation, homicidal ideation, or >= Common Terminology Criteria for Adverse Events [CTCAE] Grade 3 anxiety)
Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
Patients must be, in the opinion of the Investigator, available and compliant for treatment and follow-up.
Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment
Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
Patients are ineligible if they have a history of any underlying medical or psychiatric conditions or require any medications or treatment that in the opinion of the principal investigator may interfere with compliance, make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated or would interfere with the patient’s ability to participate in the trial
Any condition that in the opinion of the principal investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing the study requirements
Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
History/evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Has an Underlying medical condition that would preclude study participation.
Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the study drug.
Any underlying medical condition that, in the Investigator's opinion, will make the administration of study treatment hazardous to the patient, or would obscure the interpretation of adverse events.
Any malabsorption condition.
Uncontrolled concurrent illness, or any underlying medical condition, which in the principal investigator’s opinion will make the administration of ibrutinib hazardous or obscure the interpretation of adverse events
No other illness that in the opinion of the investigator would exclude the subject from participating in the study
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
In the opinion of the investigator the patients must:
history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.
Any condition that confounds the ability to interpret data from the study.
Any condition that confounds the ability to interpret data from the study
Any condition that confounds the ability to interpret data from the study
Any medical condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety, or put the study at undue risk
Subject has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the subject to receive an experimental research drug
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participation in this study
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which could jeopardize compliance with the protocol
Any condition that confounds the ability to interpret data from the study.
Serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study
History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.
History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.
History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator or the Gilead medical monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completion
Underlying medical condition (eg, a condition associated with diarrhea) that, in the investigator’s opinion, would make the administration of either study drug or both study drugs hazardous to the subject or obscure the interpretation of toxicity determination or adverse events
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of lenalidomide capsules, or put the study outcomes at undue risk
Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Clinically significant infections as judged by the treating investigator. Subjects must not have been diagnosed with human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study. Subjects should be tested for hepatitis B or C or HIV infection during screening only if they are considered by the investigator to be at high risk for these infections.
Medical condition or organ system dysfunction which, in the investigator opinion, could interfere with absorption or metabolism of ibrutinib
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any reason that, in the opinion of the Investigator, contraindicates that the patient participates in the study
Any malabsorption condition.
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Presence of any condition which makes the patient unsuitable
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Patients with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the protocol principal investigator, excess risk associated with study participation or study agent administration
Any condition that confounds the ability to interpret data from the study
Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vector hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection.
Have other significant medical conditions well-controlled and stable in the opinion of the investigator for at least 30 days prior to Day 1
Have evidence of any other serious systemic disease, including active bacterial or fungal infection, or any medical condition that, in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
Have any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study
Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (PI)
Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment
Subject has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the subject to receive an experimental research drug
Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of Adverse Events, such as a condition associated with frequent diarrhoea
History of another malignancy that in the opinion of the investigator may compromise the outcome of the study
Any reason why, in the opinion of the investigator, the patient should not participate.
Subjects must be stable and, in the opinion of the investigator, be expected to complete 4 week treatment period.
Any new condition or worsening of existing condition that could make the patient unsuitable for participation, or interfere with the patient participating in and/or completing the study
Any other concomitant serious illness or organ system dysfunction as per investigator assessment
Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years
Any clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this study
Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements
Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (PI)
Presence of underlying medical condition that in the opinion of the investigator or sponsor could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of panobinostat and ipilimumab in treated subjects
Requires myelofibrosis therapy, in the opinion of the investigator
Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigators, would preclude them from meeting the study requirements are not eligible
Any medical or other condition that in the opinion of the investigator would preclude the subject's participation in a clinical study
Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or compliance with the protocol.
Subject is diagnosed with a known medical condition associated with a hypercoagulable state.
Any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Any other medical condition that in the opinion of the investigator may interfere with a subject participation in, or compliance with, the study
Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk
Any life-threatening illness, medical condition, organ system dysfunction, need for profound anticoagulation, or bleeding disorder, which, in the investigator's opinion, could compromise the subject's safety
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The patient has any medical condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities.
Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
Subject has any condition which makes the subject unsuitable for study participation, including any contraindications of azacitidine.
A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.
Participation in any other immunotherapy treatment, that in the opinion of the principal investigator would be unsafe to receive further checkpoint blockade immunotherapy.
Active and uncontrolled disease/infection that in the opinion of the treating physician and principal investigator may affect the ability to participate in the trial or put the patient at unduly high risk
Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements; Note: Patients who are likely to require surgery or radiation for NF2-related tumors during the first year of treatment in the investigator’s opinion should not be enrolled on this clinical trial
Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;
Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator. Intraoperative Eligibility Criteria:
Any malabsorption condition
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Patients with any life threatening illness, medical condition or organ system dysfunction that in the opinion of the investigator could compromise the subject’s safety, interfere with absorption of metabolism of study drugs or put the study outcomes at undue risk
Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion could interfere with the absorption or metabolism of ibrutinib
Any medical condition or organ system dysfunction which, in the investigator’s opinion, could compromise the patient’s safety, interfere with the absorption or metabolism of ibrutinib
Patient has any unstable medical condition that would make it unsafe to undergo TURBT.
No serious disease or condition that, in the opinion of the investigator, would compromise the patient’s ability to participate in the study
Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include, but are not limited to:
Any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study
In the opinion of the investigator would benefit from systemic therapy
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk, including but not limited to:\r\n* Moderate to severe hepatic impairment (Child-Pugh classes B and C)
Subject has any other condition or reason that, in the opinion of the investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of safety data.
Any other clinically significant medical or psychological disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713
Any medical condition which, in the investigator's opinion, could compromise the patient's safety
Has any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.
Patients with serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug
A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
Active collagen-vascular disease that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
Any medical condition which, in the investigator's opinion, makes the patient unsuitable for participation
Pending visceral crisis, in the opinion of the treating investigator
Any serious co-morbid condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiography (ECG) finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of idelalisib; or impair the assessment of study results
Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowed
Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Any medical condition which, in the investigator's opinion, could compromise the patient's safety
Any condition or organ toxicity deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocol
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any condition that confounds the ability to interpret data from the study
Any condition that, in the opinion of the treating physician, would exclude the subject from receiving bevacizumab. Examples may include but are not limited to:
Any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.
History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation
Patient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study.
Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment
The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.
Participant has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study.
Patient, in the opinion of the investigator, is likely to be poorly compliant
Willingness to undergo core biopsies at baseline and mid-cycle 1 unless contraindicated by medical risk in the opinion of the treating physician and discussed with the principal investigator
Other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowed
Medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject
Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study’s endpoints
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at undue risk
Any medical intervention or other condition which, in the opinion of the principal investigator could compromise adherence with study requirements or otherwise compromise the study’s objectives
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk.
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
In the opinion of the investigator, subject has rapidly progressing disease, OR has life expectancy of less than 6 months, OR would be unable to receive at least one cycle of therapy.
Significant co-morbid condition or disease which in the judgment of the investigator would place the patient at undue risk or interfere with the study; examples include, but are not limited to cirrhotic liver disease, sepsis, or recent significant traumatic injury
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib and/or ACP-319, or put the study outcomes at undue risk.
A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the patient to receive protocol therapy
Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator’s judgment, would interfere with participation in the trial
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the participant
In the opinion of the investigator, patient must be able to receive at least 2 cycles of treatment
Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
Any serious ongoing condition, such as an untreated infection or organ dysfunction
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any medical condition which, in the opinion of the investigator, puts the patient at risk of potentially serious complications while on study treatment
Any other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Have any condition or illness that, in the opinion of the investigator, would compromise participants safety or interfere with evaluation of the drug study.
Any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures
Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
Concurrent serious illness which, in the opinion of the investigator, would place the patient at unreasonable risk from study therapy;
Willingness to swallow pills and no medical condition that would interfere with this
Any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which place the patient at undue risk, or complicates the interpretation of safety data
Medical condition that would make prednisone (corticosteroid) use contraindicated
Any other medical condition that in opinion of investigator would place patient at increased risk for toxicity during pomalidomide treatment (i.e. history of recurrent or serious thromboembolic events)
A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk.
Any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, places the patient at undue risk, or complicates the interpretation of safety data
Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
COHORT A: Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
COHORT B: Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Any prior or co-existing medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study
Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the subject's risk while participating in this study
Have any past or current, acute or chronic concurrent medical condition/illness or therapy that, in the opinion of the investigator, would make the subject unsuitable for the clinical trial or unable to comply with follow up visits
Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study
The patient has any condition that confounds the ability to interpret data from the study.
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Subject has any condition which makes the subject unsuitable for study participation (e.g. ophthalmic conditions such as advanced cataracts).
High likelihood or protocol non-compliance (in opinion of investigator)
Study team (PI, co-investigator [I], and/or research nurse) may deny enrollment if in the study team’s opinion, the candidate may not be adherent to the treatment protocol including scheduled follow-ups
Subjects with acute hepatitis B are not eligible; subjects with chronic hepatitis are eligible if their condition is stable and, in the opinion of the investigator, if consulted, would not pose a risk to subject safety
Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk
Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:
Any other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Any condition which, in the opinion of the investigator, would preclude participation in this trial
Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician
Any condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
Any condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable risk
Any malabsorption condition
Patients with any significant medical illnesses or infection that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are not eligible for participation
Any prior or co-existing medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study
Current life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the patient’s safety, or put the study at risk
Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs
Any medical or other condition that in the opinion of the investigator(s) would preclude the subject's participation in a clinical study or would preclude them from completing the study.
Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment
Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
the patient is less than 65 years of age but has significant comorbid condition(s) that are, in the opinion of the investigator, likely to have a negative impact on tolerability of HDT-SCT
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any significant concurrent illness that would, in the judgment of the treating physician/principal investigator, compromise patient safety or compliance, or study participation
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of BPX-201 and AP1903 hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
Active infection requiring IV antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy
Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs
Participation in another clinical trial unless approved by the lead principal investigator
Any clinically significant medical disease or condition that, in the treating investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease, that in the opinion of the investigator, would adversely affect his/her participation in the study.
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
Any malabsorption condition
The patient has a medical or psychiatric condition that constitutes an unacceptable risk for participation in this trial, in the judgment of the treating physician
Any condition which, in the opinion of the investigator, would preclude participation in this trial
Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely
Any laboratory abnormalities, which in the opinion of the investigator, may put the subject at risk if participating in the study; for example:
Other medical or psychiatric illness or organ dysfunction that, in the opinion of the investigator, would either compromise the patient’s safety or interfere with the evaluation of the safety of bevacizumab
Uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
Any physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient's ability to comply with the trial procedures
Any other condition or prior therapy, which in the opinion of the PI, would make the subject unsuitable for the study.
Any other medical intervention or condition, which, in the opinion of the PI could compromise patient safety or adherence with the study requirements
Any other concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol
Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
In the opinion of the investigator, the patient is felt not to be appropriate for the study
Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion.
Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient\r\n* Those patients with medical conditions that are controlled with medical therapy are eligible
Have any clinically significant medical conditions that are unstable, progressive, or inadequately controlled in the opinion of the investigator, that would pose a potential risk for the subject, result in poor compliance with the study requirements, or require treatment with an excluded medication or treatment during the study
Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrollment
Any condition which in the investigator's opinion makes the subject unsuitable for study participation
Patient with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
Patients must not have a history of any condition (social or medical) that, in the opinion of the Investigator, might interfere with the patient’s compliance with the protocol or pose additional or unacceptable risk to the patient
Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment
Any uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Any underlying medical or psychiatric condition, which in the opinion of the investigator/sub-investigator will make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective
Any other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol
Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy
Pending visceral crisis, in the opinion of the treating investigator
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug
The patient has any condition that will place the patient at undue risk or discomfort as a result of adherence to study procedures
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the option of the investigator may represent a risk for the patient
Serious nonmalignant or malignant disease or psychiatric illness, which, in the opinion of the investigator would compromise protocol objectives or interfere with participation
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Any underlying medical or psychiatric condition that, in the opinion of the investigator, could make the administration of ipilimumab hazardous or could obscure the interpretation of adverse events
In the opinion of the treating investigator, patients must have adequate cognitive abilities to complete the neurocognitive components of the study.
Patients must not have any significant medical or psychiatric illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
Patients must not have any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Other unspecified reasons that, in the opinion of the investigator or Millennium, make the patient unsuitable for enrollment
Patient may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the patient is not capable of being compliant
Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment
General medical condition: fit for the proposed surgery and/or radiation treatment as determined by the treating investigator
History of medical or psychiatric disease which, in the view of the principal investigator, would preclude safe treatment
Subject has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
Any malabsorption condition
Any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
Inclusion Criteria:\n\n        Participants will be required to meet all of the following criteria to be considered\n        eligible for the study:\n\n          -  Have a confirmed diagnosis of HCC. Biopsy is preferred but is not required.\n\n          -  Male and female participants who are ?18 years of age.\n\n          -  In the opinion of the investigator, the participants have a life expectancy of at\n             least 12 weeks.\n\n          -  Able to take food or nutritional support orally.\n\n          -  On sorafenib for at least 4 weeks prior to randomization. Dose adjustments are allowed\n             prior to randomization.\n\n          -  Have a Karnofsky Performance Score (KPS) equal to or greater than 50.\n\n          -  Have a cirrhotic status of Child-Pugh Class A or B7.\n\n          -  Have the following laboratory parameters:\n\n               -  a. Platelet count ?50 x 10E9/L.\n\n               -  b. Total bilirubin ?1.5 mg/dL (?1.0 mg/dL for primary biliary cirrhosis). If\n                  total bilirubin >1.5 mg/dL but <3.0 mg/dL, a patient could be enrolled after\n                  consultation with the Medical Monitor. If total bilirubin is >3.0 mg/dL, but the\n                  value has been constant for a period of greater than 3 months, a patient could be\n                  enrolled after consultation with the Medical Monitor.\n\n               -  c. Serum creatinine ?1.5 x upper limit of normal (ULN) or creatinine clearance\n                  >60 mL/min calculated using Cockcroft-Gault.\n\n               -  d. Serum albumin ?3.5 g/dL and/or C-reactive protein (CRP) ?3 mg/L\n\n          -  Able to provide written informed consent prior to any study specific screening\n             procedures with the understanding that the patient has the right to withdraw from the\n             study at any time, for any reason without prejudice.\n\n        Exclusion Criteria:\n\n        Participants must not have any of the following criteria to be considered eligible for\n        inclusion in the study:\n\n          -  The patient has a history of another primary cancer, with the exception of: a)\n             curatively resected non-melanomatous skin cancer; b) curatively treated cervical\n             carcinoma in-situ; or c) other primary solid tumor with no known active disease\n             present that in the opinion of the investigator will not affect patient outcome in the\n             setting of current HCC diagnosis.\n\n          -  Contraindication to sorafenib, propranolol, etodolac, or placebo.\n\n          -  Patient currently on beta-blockers for the treatment of portal hypertension or\n             arrhythmia. [Patients on beta blockers for the treatment of hypertension are allowed\n             if they change to a different drug class, e.g. some classes of angiotensin-converting\n             enzyme (ACE) inhibitors, for controlling hypertension at least one week before\n             randomization].\n\n          -  Body mass index (BMI) <17.5 kg/m2.\n\n          -  History or evidence of cardiac disease: congestive heart failure; New York Heart\n             Association class 2 or greater; active coronary artery disease; unstable angina,\n             cardiac arrhythmias requiring anti-arrhythmic therapy, atrioventricular block of\n             second or third degree, or uncontrolled hypertension. Patients with recent (less than\n             6 months) myocardial infarction (MI) or coronary revascularization.\n\n          -  Hypotension at the time of screening (i.e., systolic blood pressure <90 mmHg,\n             diastolic blood pressure <60 mmHg).\n\n          -  Resting heart rate <60 bpm at time of screening.\n\n          -  Participants with a recent diagnosis of bleeding varices that has not been resolved\n             for a minimum period of 4 weeks.\n\n          -  Any uncontrolled intercurrent illness that, in the opinion of the Investigator, may\n             interfere with study evaluation.\n\n          -  On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine,\n             dopamine, dobutamine, epinephrine, isoproterenol).\n\n          -  Active clinically serious infections [>Grade 2 National Cancer Institute (NCI)-Common\n             Terminology Criteria for Adverse Events (CTCAE) version 4.0].\n\n          -  Known history of human immunodeficiency virus (HIV) infection.\n\n          -  Known central nervous system tumors including metastatic brain disease.\n\n          -  Clinically significant gastrointestinal (GI) bleeding within 30 days prior to\n             Screening.\n\n          -  Substance abuse, medical, psychological or social conditions that may, in the in the\n             opinion of the investigator, interfere with the patient's participation in the study\n             or evaluation of the study results.\n\n          -  Known or suspected allergy to the investigational agents or any agent given in\n             association with this trial (hypersensitivity reaction, hives, rash, difficulty\n             breathing swelling of face, lips, tongue, or throat).\n\n          -  Inability to swallow oral medications.\n\n          -  Any condition that is unstable or which in the opinion of the Investigator could\n             jeopardize the safety of the patient and his/her compliance in the study.\n\n          -  Pregnant or breastfeeding participants. Women of childbearing potential\n             (non-childbearing potential is defined as menopausal for at least 2 years,\n             post-bilateral tubal ligation for at least 1 year, post-bilateral oophorectomy or\n             post-hysterectomy) must have a negative urine pregnancy test performed within 10 days\n             prior to the start of study drug. Both men and women enrolled in this trial must use\n             adequate double-barrier birth control measures [2 types of an acceptable form of\n             FDA-approved contraception (e.g., barrier method, Depo-Provera™, Norplant™, Ortho\n             Evra® [birth control patch], oral contraceptives)] during the course of the trial.\n\n          -  Participation in any other investigational trial in which receipt of investigational\n             drug or device occurred within 30 days prior to screening for this study.
Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug
Have serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this study
Serious concurrent illness, which in the opinion of the investigator or an authorized physician sub-investigator would interfere with participation in this clinical study
Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
Suffer from any other condition or illness that would compromise safety or interfere with evaluation of the drug
Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
in the opinion of the Investigator, the subject does not have progressive disease
Patients with psychiatric or addictive disorders that, in the opinion of the investigator, would preclude obtaining informed consent
Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial or the investigator’s belief that the subject is medically unfit to receive eribulin mesylate and atezolizumab or unsuitable for any other reason
Any uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of entinostat capsules, or put the study outcomes at undue risk
The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety or put the study outcomes at risk
All other significant diseases (e.g., inflammatory bowel disease) that, in the opinion of the investigator, might impair the subject's tolerance of trial treatment.
Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorption
Any other condition that, in the opinion of the investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study
Any medical intervention, condition or any other circumstance which in the opinion of the investigator or the sponsor's medical monitor, could compromise adherence to study procedures or study objectives.
Any serious underlying medical or psychiatric condition (e.g., alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to receive or tolerate the planned treatment, to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or that would confound the results of the study.
Any life-threatening illness, medical condition, including uncontrolled diabetes mellitus (DM), or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk
Any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would impair with their ability to receive or tolerate the planned treatment, or interfere with the study evaluations or optimal participation in the study.
Any medical condition which would, in the investigator's opinion, compromise the patient's ability to mount an immune response, renders the patient a poor candidate for this trial or could confound the results of the study
Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study.
Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician
Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
Patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult
No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study
Previous medical history, or evidence, of an intercurrent illness that at the discretion of the principal investigator may compromise the safety of the subject in the study
Any condition, including the presence of laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study
Any other medical condition or laboratory evaluation that, in the treating physician’s or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
Medical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocol
Patients with any other medical condition or reason, in that investigator’s opinion, makes the patient unstable to participate in a clinical trial
Subject has concurrent corneal disorder or any ophthalmologic condition which, in the investigator's opinion, makes the subject unsuitable for study participation (i.e., advanced cataracts, glaucoma).
Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation.
Uncontrolled intercurrent illness (i.e., active infection) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the patient's ability to participate
The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study
Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject's ability to safely receive treatment or complete study assessments
Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
Is actively participating in another investigational clinical study which, in the Investigator's or Sponsor's opinion, would interfere in this study.
Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:
Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
Any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study.
Any malabsorption condition which, in the opinion of the treating physician, will affect the absorption of any of the agents used in this study.
Any condition, which, in the site investigator's opinion, makes the subject unsuitable for trial participation.
Any condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial.
Subject is a female who is pregnant or is breast feeding 24. Subject is unwilling or unable to comply with the protocol, in the opinion of the investigator 25. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 26. Subject has any condition that confounds the ability to interpret data from the study
Any other reason the investigator considers the patient should not participate in the study
Uncontrolled intercurrent illness involving any other organ system or a social situation that would, in investigator's opinion, place the subject at unacceptable risk, limit compliance, or confound interpretation of safety or other results.
Significant gastrointestinal disorder(s), in the opinion of the principal investigator (e.g., Crohn’s disease, ulcerative colitis, extensive gastric resection)
No other medical, or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen
Subject has concurrent corneal disorder or any ophthalmologic condition that makes the subject unsuitable for study participation (e.g., advanced cataracts, glaucoma).
Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
The presence of any medical condition that the Investigator deems incompatible with participation in the trial
DONOR: The presence of any medical condition that the investigator deems incompatible with participation in the trial
Any other condition which, in the opinion of the Investigator, would preclude participation in this trial
Uncontrolled intercurrent illness (i.e., active infection ? Grade 2) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the subject's ability to participate.
The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the subject inappropriate for inclusion in this study.
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Subject has concurrent corneal disorder or any ophthalmologic condition which makes the subject unsuitable for study participation .
Subject has any condition which makes the subject unsuitable for study participation.
Any prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study
Any other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ECG), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the study
Subject is a family member or employee of the investigator
Concurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the subject or impair the assessment of the study results.
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
In opinion of Investigator, make subject unsuitable for study.
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any condition that confounds the ability to interpret data from the study.
Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapy
The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
Any reason why, in the opinion of the investigator, the patient should not participate
Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive treatment (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the subject’s risk by participating in this study)
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug
Any concurrent disease and/or medical condition that, in the opinion of the Investigator, would prevent the subject's participation.
Participants must, in the opinion of the investigator, be capable of complying with the protocol
Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the patient’s safety, or put the study at risk; any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the subject at undue risk to undergo therapy with ibrutinib
Any other condition which, in the opinion of the investigator, would preclude participation in this trial
Significant, concurrent, uncontrolled medical condition which, in the opinion of the investigator, may interfere with patient participation in the study.
Must in the opinion of the investigator be capable of complying with this protocol
Any serious, active underlying medical condition that would impair the ability of the subjects to receive study treatment
Any condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapy
Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowed
have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.
Any condition which in the investigator’s opinion deems the subject an unsuitable candidate to receive study drug
Acute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safety
Subject has an existing medical condition that is likely to require the use of diathermy in the future
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Any condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the study
Concomitant disease or condition that would interfere with the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study.
Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair the ability to receive or tolerate the planned treatment
Suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the study drug
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, heart failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Any condition that, in the clinical judgment of the treating physician, is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk.
Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy
Any condition or organ toxicity that is deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocol
Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment; similarly, any unstable medical condition that in the opinion of the treating physician or study investigators, would interfere with determination of the study objectives
Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapy
Use of any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient.
Medical, psychological or surgical condition which the investigator feels might compromise study participation
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
Participants must, in the opinion of the investigator, be capable of complying with the protocol
Any other medical condition that, in the opinion of the principal investigator (PI), may interfere with a subject's participation in or compliance with the study
Has any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial.
History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study.
Any other medical condition that, in the opinion of the PI, may interfere with a subject's participation in or compliance with the study
Have serious pre-existing medical conditions (at the discretion of the investigator).
Any condition that confounds the ability to interpret data from the study.
Psychiatric or addictive disorders or other conditions that in the opinion of the investigators would preclude the patient from complying with the study protocol
Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study’s endpoints
Patients who have serious intercurrent medical illness which in the opinion of the investigator would compromise the patient's ability to tolerate this therapy
Key Inclusion Criteria:\n\n          -  Received an autologous or allogeneic HCT using any conditioning regimen\n\n          -  Evidence of new abnormalities on chest X-ray obtained < 48 hours prior to screening,\n             determined to be consistent with LRTI by the local radiologist, relative to the most\n             recent previous chest X-ray. If chest X-ray is not available, a chest X-ray must be\n             obtained for screening.\n\n          -  Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and\n             lower (eg, induced sputum, bronchoalveolar lavage, lung biopsy, but not spontaneous\n             sputum) respiratory tract as determined by local testing (eg, polymerase chain\n             reaction, direct fluorescence antibody, respiratory viral panel assay, or culture).\n             All samples must have been collected ? 6 days prior to Day 1, or as determined at\n             screening as per protocol.\n\n          -  An informed consent document signed and dated by the participant or a legal guardian\n             of the participant and investigator or his/her designee.\n\n          -  A negative urine or serum pregnancy test is required for female participants (unless\n             surgically sterile or greater than two years post-menopausal)\n\n          -  Male and female participants of childbearing potential must agree to contraceptive\n             requirements as described in the study protocol\n\n          -  Willingness to complete necessary study procedures and have available a working\n             telephone or email\n\n        Key Exclusion Criteria:\n\n        Related to concomitant or previous medication use:\n\n          -  Use of non-marketed (according to region) investigational agents within 30 days, OR\n             use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of\n             screening, whichever is longer, OR use of any investigational RSV vaccines after HCT\n\n          -  Use of a moderate or strong cytochrome P450 enzyme inducer including but not limited\n             to rifampin, St. John's Wort, carbamazepine, phenytoin, efavirenz, bosentan,\n             etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of study\n             drug\n\n        Related to medical history:\n\n          -  Pregnant, breastfeeding, or lactating females\n\n          -  Unable to tolerate nasal sampling required for this study, as determined by the\n             investigator\n\n          -  Known history of HIV/AIDS with a CD4 count <200 cells/?L within the last month\n\n          -  History of drug and/or alcohol abuse that, in the opinion of the investigator, may\n             prevent adherence to study activities\n\n        Related to medical conditions:\n\n          -  Requiring invasive mechanical ventilation at the time of randomization\n\n          -  Documented to be positive for other respiratory viruses (limited to influenza,\n             parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus),\n             from the lower respiratory tract sample as determined by local testing\n\n          -  Clinically significant bacteremia or fungemia within 7 days prior to screening that\n             has not been adequately treated, as determined by the investigator\n\n          -  Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to\n             screening that has not been adequately treated, as determined by the investigator\n\n          -  Excessive nausea/vomiting at screening, as determined by the investigator, or an\n             inability to swallow pills that precludes oral administration of the investigational\n             medical product (for individuals without an NG tube in place)\n\n          -  Any condition which, in the opinion of the investigator, would prevent full\n             participation in this trial or would interfere with the evaluation of the trial\n             endpoints\n\n        Related to laboratory results:\n\n          -  Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)\n\n          -  Clinically significant aspartate aminotransferase/alanine aminotransferase, as\n             determined by the investigator\n\n          -  Clinically significant total bilirubin, as determined by the investigator\n\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria:\n\n          -  Received an autologous or allogeneic HCT using any conditioning regimen\n\n          -  Documented to be RSV-positive as determined by local testing (eg, polymerase chain\n             reaction, direct fluorescence antibody, respiratory viral panel assay, or culture)\n             using an upper respiratory tract sample collected ? 6 days prior to Day 1\n\n          -  New onset of at least 1 of the following respiratory symptoms for ? 7 days prior to\n             Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of\n             these chronic (associated with a previously existing diagnosis, eg, chronic\n             rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms ? 7 days\n             prior to Day 1\n\n          -  No evidence of new abnormalities consistent with LRTI on a chest X-ray relative to the\n             most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is\n             not available or was not obtained during standard care < 48 hours prior to screening,\n             a chest X-ray must be obtained for screening\n\n          -  O2 saturation ? 92% on room air\n\n          -  An informed consent document signed and dated by the participant or a legal guardian\n             of the participant and the investigator or his/her designee\n\n          -  A negative urine or serum pregnancy test is required for female participants (unless\n             surgically sterile or greater than two years post-menopausal)\n\n          -  Male and female participants of childbearing potential must agree to contraceptive\n             requirements as described in the study protocol\n\n          -  Willingness to complete necessary study procedures and have available a working\n             telephone or email\n\n        Exclusion Criteria:\n\n        Related to concomitant or previous medication use:\n\n          -  Use of non-marketed (according to region) investigational agents within 30 days, OR\n             use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of\n             screening, whichever is longer, OR use of any investigational RSV vaccines after HCT\n\n        Related to medical history:\n\n          -  Pregnant, breastfeeding, or lactating females\n\n          -  Unable to tolerate nasal sampling required for this study, as determined by the\n             investigator\n\n          -  Known history of HIV/AIDS with a CD4 count <200 cells/?L within the last month\n\n          -  History of drug and/or alcohol abuse that, in the opinion of the investigator, may\n             prevent adherence to study activities\n\n        Related to medical condition at screening:\n\n          -  Documented to be positive for other respiratory viruses (limited to influenza,\n             parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus)\n             within 7 days prior to the screening visit, as determined by local testing (additional\n             testing is not required)\n\n          -  Clinically significant bacteremia or fungemia within 7 days prior to screening that\n             has not been adequately treated, as determined by the investigator\n\n          -  Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to\n             screening that has not been adequately treated, as determined by the investigator\n\n          -  Excessive nausea/vomiting at screening, as determined by the investigator, or an\n             inability to swallow pills that precludes oral administration of the investigational\n             medical product (for participants without an nasogastric tube in place)\n\n          -  Any condition which, in the opinion of the investigator, would prevent full\n             participation in this trial or would interfere with the evaluation of the trial\n             endpoints\n\n        Related to laboratory results:\n\n          -  Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)\n\n          -  Clinically significant aspertate aminotransferase/alanine aminotransferase, as\n             determined by the investigator\n\n          -  Clinically significant total bilirubin, as determined by the investigator
A medical condition that precludes adequate study treatment or increases patient risk
Psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance; any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of nivolumab and ipilimumab hazardous or obscure the interpretation of adverse events (AEs)
Requires myelofibrosis therapy, in the opinion of the investigator
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Active infection or other medical condition that would make corticosteroids (i.e. dexamethasone) use contraindicated
Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject including but not limited to uncontrolled infection, heart failure, pulmonary hypertension, etc.
Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection (e.g. prosthetic hip).
Any underlying medical or psychiatric condition, which in the opinion of the investigator/sub-investigator will make the administration of ipilimumab or nivolumab hazardous or obscure the interpretation of adverse events (AE)s, such as a condition associated with frequent diarrhea
Have serious pre-existing medical conditions (at the discretion of the investigator, such as severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation).
Concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia
Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator or medical monitor.
Known inability to undergo neoadjuvant gemcitabine and cisplatin combination treatment due to pre-existing medical conditions in the opinion of the treating physician or investigator
Any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject
Any other condition that in the investigator's opinion would not make the subject a good candidate for the clinical study,
A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures
Have serious preexisting medical conditions (left to the discretion of the investigator).
Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.
History of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study.
Patient has any other medical, psychiatric, or social condition, including substance abuse that in the opinion of the investigator would preclude participation in the study.
The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study.
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study
Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results
Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen
Ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the Investigator's medical opinion, should exclude participation in the study
Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or compliance with the protocol
Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy.
The subject is judged unsuitable for study participation by the Investigator for any other reason.
Any concurrent condition which in the investigator’s opinion makes it undesirable for the subject to participate in this trial or which would jeopardize compliance with the protocol
Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
Any condition that confounds the ability to interpret data from the study
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individual's NHL
A life threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the individual's safety or interfere with the absorption or metabolism of ENTO
Any condition that, in the opinion of the investigator or the Sponsor, makes the patients unsuitable for the study.
Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Symptomatic patients who, in the opinion of the investigator, may benefit from docetaxel-based chemotherapy
Any underlying medical condition that in the principal investigator’s opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events
Subject with significant or uncontrolled cardiac, renal, hepatic or other systemic disorders; or significant psychological conditions at baseline that in the investigator's opinion, makes the subject unsuitable for study participation.
Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria)
Impending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.
Any medical condition, which in the opinion of the study Investigator, places the participant at an unacceptably high risk for toxicities
Any medical condition that confounds the ability to interpret data from the study. This includes subjects with known psychiatric disorders.
Patient with concurrent severe and/or uncontrolled medical conditions that, in the opinion of the investigator, may impair participation in the study or the evaluation of safety and/or efficacy
Any condition that places the patient at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol.
Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the patient’s safety, or put the study at risk
Any condition, which in the opinion of the investigator, would preclude participation in this trial
Any history of or concomitant condition that, in the opinion of the investigator not to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment
Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
Illness or any other circumstances (as defined by the investigator), which would preclude safe performance of study procedures or compromise the ability of the patient to consent to study
Patients with >= grade 2 or greater diarrhea despite maximal medical management due to medications or a medical condition such as Crohn's disease, malabsorption
Significant gastrointestinal disorders, in the opinion of the Investigator
Patients with a co-morbid condition(s) that, in the opinion of the investigator, prevents safe surgery/biopsy procedure
Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)
Any condition which in the investigator's opinion makes the patient unsuitable for study participation.
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
Any condition that is unstable and could jeopardize the subject's participation in the study.
The presence of any medical condition that the Investigator deems incompatible with participation in the trial
DONOR: The presence of any medical condition that the Investigator deems incompatible with participation in the trial
Any condition that is unstable and could jeopardize the subject's participation in the study.
Have a history of thrombocytopenia with complications including hemorrhage or bleeding >= grade 2 using NCI CTCAE v4.03, 14 June 2010 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator
Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol
The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
Clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the patient; alter the absorption of the study drugs; or impair the assessment of study results.
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Active infection or antibiotics within one-week prior to study, including unexplained fever; any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator, could prevent adequate informed consent or compromise participation in the clinical trial
Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible
Any condition which, in the opinion of the investigator, would preclude participation in this trial
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible.
Any other clinically significant medical disease or psychiatric condition that, in the Investigator's opinion, may interfere with protocol compliance
Any condition which in the Investigator’s opinion deems the patient an unsuitable candidate to receive treatment
History of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study
Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities;
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Any clinically significant concomitant disease or condition that could interfere with, or for which treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the principal investigator, pose an unacceptable risk to the subject in the study
The risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
History of any condition or uncontrolled intercurrent illness that in the opinion of the local investigator might interfere with or limit the patient's ability to comply with the protocol or pose additional or unacceptable risk to the patient.
Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consent
Subject is hospitalized for a condition other than VOC
Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible
Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism, Paget's disease of bone, or any other concurrent severe or uncontrolled concomitant medical condition that, in the opinion of the Investigator, would preclude participation in this study
Patients who in the opinion of the Investigator would not be able to provide reliable study data or be available for study follow-up
Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule.
In the opinion of the Investigator, subjects with a low chance of survival during the first 5 days of treatment.
Subjects may not have an underlying medical condition that in the opinion of the investigator could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of dasatinib and ipilimumab in treated subjects
The patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.
Any malabsorption condition
Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
Any condition which in the investigator's opinion makes the patient unsuitable for the study participation
Clinical judgement by the investigator that the patient should not participate in the study
Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study Cancer-Specific Exclusion Criteria
Subjects can participate in the study if in the opinion of the investigator it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data.
Serious concurrent medical illness that in the opinion of the investigator would compromise patient safety or preclude accurate assessment of outcome.
Serious concurrent psychiatric disorder that in the opinion of the investigator would compromise patient safety or preclude accurate assessment of outcome.
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Patients with any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Systemic cardiac disease that would, in the opinion of the investigator or medical monitor, interfere with assessment of efficacy or safety of the drug
Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair their ability to receive or tolerate the planned treatment
Donor must not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation.
Subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
Any medical or other condition which, in the opinion of the PI or designee, will preclude participation in a clinical trial.
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea
Other significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the Investigator's opinion, will impact study participation.
Have serious preexisting medical conditions that would preclude participation in the study
Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor
Subjects must in the opinion of the Investigator be capable of complying with this protocol
A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment
Subjects who, in the opinion of the investigator, are not likely to survive beyond 48 hours from Baseline.
Other significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the investigator's opinion, will impact study participation.
Medical, psychological or surgical condition which the investigator feels might compromise study participation
Any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol.
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should consult the study chair
The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
Any reason why, in the opinion of the investigator, the patient should not participate
Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
Any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data
Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator or co-investigators, could prevent adequate informed consent or compromise participation in the clinical trial
No medical, psychological or surgical condition which the investigator feels might compromise study participation
Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Any reason why, in the opinion of the investigator, the patient should not participate
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment
Any other medical condition for which treatment with ipilimumab or nivolumab would be medically contraindicated
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Subject has any condition which may require treatment during the study and may make the subject unsuitable for study participation.
Any condition that in the opinion of the investigator, would preclude participation in this study
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the subject’s risk by participating in this study)
Subject has concurrent corneal disorder or any ophthalmologic condition which, in the Investigator's opinion, makes the subject unsuitable for study participation (e.g., advanced cataracts, glaucoma, or subject is unable to undergo a comprehensive ophthalmologic exam).
Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Any condition or medical problem in addition to the underlying malignancy and organ dysfunction that the investigator feels would pose unacceptable risk
Patients who are severely underweight in the opinion of the investigator
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug
Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions)
Patients with a condition that, in the opinion of the investigator, would interfere with the absorption of oral medication will be excluded from the study
Any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, significantly increase the subject's risk of participating in this study
No known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
Patient has any other condition that, in the opinion of the investigator, may impact the absorption of oral medications
Presence of a severe unmanaged psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
PATIENT EXCLUSION: Current radiation therapy that in the opinion of the investigator is significantly affecting pain
Any other condition which, in the opinion of the investigator, would make the subject unsuitable for trial participation
Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol treatment
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
PATIENTS: Existence of co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol
Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol.
Any other medical condition or laboratory evaluation that, in the treating physician‘s or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
Have a history of thrombocytopenia with complications including hemorrhage or bleeding of ?Grade 2 per NCI CTCAE v4.03 that required medical intervention or have any hemolytic condition or coagulation disorder that would make participation unsafe in the opinion of the investigator.
Have signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social condition that, in the opinion of the investigator, make it undesirable for the patient to participate in the study or that could jeopardize compliance with the protocol.
Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
Any condition or reason that interferes with ability to participate in the study, tolerate treatment or assessments associated with the protocol, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Medical Monitor
Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
Any condition or reason that interferes with ability to participate in the study, tolerate treatment or assessments associated with the protocol, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Medical Monitor.
Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
Life-threatening illness unrelated to cancer that could, in the investigator's opinion, make the participant not appropriate for this study.
Has a clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or pulmonary disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator.
Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study
All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatment
Any condition that in the opinion of the investigator would preclude participation in this study
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk
Medical exclusions include: patients with a history of myocardial infarction or ischemic heart disease within the past six months; patients with history of epilepsy, brain damage, or symptomatic brain metastases; skin conditions such as open sores that would prevent proper application of the electrodes; or other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Any condition that, in the opinion of the enrolling investigator, would interfere with the subject’s ability to comply with the study requirements
Any condition which in the investigator’s opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
Any other condition that, in the opinion of the investigator, may impact the absorption of oral medications
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate for study participation
Presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy
In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy
Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject
Has been diagnosed with/exhibits any mental neurological disorder/disease/condition that would prevent participation in the study in the opinion of the investigator
Any condition, in the principal investigator’s opinion, that would compromise patient safety or study outcomes
In the opinion of the principal investigator (PI) or an associate investigator (AI), the subject has significant cognitive or emotional difficulties that would prevent them from being able to understand and/or participate fully in the intervention or the measures
Clinically evident cognitive and/or behavioral impairment that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoring
Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoring
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial
A serious uncontrolled medical disorder that is in the opinion of the investigator would impair the ability of the subject to receive protocol therapy
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial
Subject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infection
In the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatment
Patients who are unable to follow instructions due to their medical condition
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Either the child or the parent has a mental health or medical condition that, in the opinion of investigators or the treating oncologist, would make it difficult to participate in the study
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; examples of this would be hearing loss or neuropathy which would prevent tolerance to cisplatin, and paclitaxel administration; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard
Patients who, in the opinion of the treating physician, have a medical condition, or currently take medications, which are felt to contraindicate safe or effective administration of the standard three drug anti-emetic regimen used in this study
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
No orthopedic restrictions or neurologic deficits that would limit ability to complete the Power Protocol (based on the opinion of the investigator)
No conditions that would be exacerbated by dehydration in the opinion of the investigator
Subjects with any concurrent condition that, in the investigator’s opinion, would jeopardize the safety of the subject or compliance with the protocol
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Must not have any other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a participant’s ability to give informed consent
Medical, psychiatric condition which in the investigators opinion will affect the successful completion of study
Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive ALTENS
Known previous or concomitant serious illness (other than advanced cancer with metastatic bone disease) or medical condition, such as, HIV, significant gastrointestinal disease, or cardiovascular event that in the opinion of the investigator may worsen and/or interfere with participation in the study
History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any other reason, which in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely
History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation.
Other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's and/or Medical Monitor's judgment, precludes the participants safe participation in and completion of the study
Not a candidate for enzalutamide treatment, in the opinion of the Investigator
Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiography (ECG) finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient, including symptomatic hyperviscosity; alter the absorption, distribution, metabolism or excretion of ABT-199; or impair the assessment of study results
Subject has evidence, in the opinion of the Investigator, of either on-going systemic or pleural infection.
Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would mean participation in the study would be contraindicated.
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Significant co-morbid condition or disease which in the judgment of the principal investigator would place the patient at undue risk or interfere with the study
Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures;
Participants must, in the opinion of the investigator, be capable of complying with the requirements of this protocol
Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject’s safety or put the study outcomes at undue risk
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the study
Any condition that, in the opinion of the investigator, would preclude safe and adequate test performance
No prior renal disease that in the opinion of the attending physician would make the patient ineligible to receive the study drug
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial
Patients must not have a history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
Any medical or psychological condition or any reason that, according to the investigator’s judgment, makes the patient unsuitable for participation in the study
Any condition which in the investigator’s opinion makes the subject unsuitable for study participation
Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry
Subjects with current alcohol use, illicit drug use, or any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule
Any mental or physical condition, in the opinion of the principal investigator (PI) or PI designee, which could interfere with the ability of the subject to understand or adhere to the requirements of the study
The opinion of the treating physician determines it is not medically safe to participate in the study
Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Any condition that, as determined by the treating Investigator, confounds the interpretation of data from the study
Patients with a clinically significant abnormality on screening electrocardiogram (ECG) (taken within 12 weeks) that in the opinion of the investigator/co-investigator may increase the patient’s cardiovascular risk in this study
Patients must not have any concurrent condition which in the Investigator’s opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol
Any condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive study drug
Acute or chronic medical disorder that, in the opinion of the investigator or medical monitor, may prevent the subject from completing participation in the study
Has any other condition or prior therapy that in the opinion of the Investigator would make the patient unsuitable for the study and/or unable to comply with requirements for follow-up visits.
Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures
The investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
Any serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative Exclusion Criteria
Any uncontrolled medical condition which may place the patient at increased risk during study participation (at the discretion of the clinical investigator)
A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise (confirmed by self-report on the Health History Questionnaire, and by physician clearance; if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible)
In the opinion of the surgeon, the subject has no medical contraindications to distal pancreatectomy
In the opinion of the surgeon, the subject has medical contraindications to distal pancreatectomy
Conditions unsuitable for participation in the trial in the investigator's opinion
Significant co-morbidities (e.g., diabetes, cardiac disease, or other condition that in the opinion of the primary physician or investigators would limit participation in the intervention groups) that would preclude study participation
Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.
Any condition or therapy, which, in the opinion of the Investigator, might pose a risk to the patient or make participation in the study not in the best interest of the patient.
Any condition which in the Investigator’s opinion deems the subject an unsuitable candidate to receive study drug
Any autoimmune disease or other medical condition that, in the opinion of the investigator, would compromise the subject's safety
Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data
Other illness that in the opinion of the investigator would exclude the patient from participating in this study
RECIPIENT: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Have any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject’s successful completion of this study
Have an acute illness, as determined by the site principal investigator within 72 hours prior to study vaccination; an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol and was not due to an influenza infection
Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Any life threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
For patient aged 2 years with known mild to moderate hepatic impairment: in the Investigator's opinion the impairment does not jeopardize patient's safety during the study.
For patient aged 2 years with known mild to moderate renal impairment: in the Investigator's opinion the impairment should not jeopardize patient's safety during the study.
Patient with clinically relevant abnormal laboratory values that in the Investigator's opinion jeopardize the patient's safety during the study.
Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other condition which, in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient
Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drug
Individuals with a history of photosensitive diseases including, but not limited to, lupus erythematosus, pseudoporphyria, or other diseases that in the opinion of the study physician would pose a risk to the subject or interfere with the study
Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject
Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event
Significant unstable medical/psychiatric or substance use disorders, or medically/psychiatrically at risk in the judgment of the study physician (or licensed medical professional designated to consult in his absence) or principal investigator (PI)
Presence of any major medical condition which, in the opinion of the investigator, precludes participation in the study
Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including follow-up), or would interfere with the evaluation of the trial endpoints
Any physical or psychological condition that, in the opinion of the investigator, would post unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures
Medical conditions:\r\n* Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke\r\n* History of renal or liver disease\r\n* Prior ovarian or endometrial cancer\r\n* Stopped or started hormone replacement within 8 weeks\r\n* Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for RPFNA.
Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
Any other significant acute or chronic diseases that in the investigator's opinion would exclude the subject from the trial
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for core biopsy or the trial
ELIGIBILITY FOR THE 2-YEAR EXTENSION: Patient has a significant medical or psychiatric condition that would make the patient a poor protocol candidate
Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data
Any other condition that, in the opinion of the investigator, makes the patient or donor ineligible for the study
Any condition that in the opinion of the investigator raises concerns about protocol compliance
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study intervention
Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for RPFNA or the trial
Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
Significant medical or psychiatric problems which would make the subject a poor protocol candidate, in the opinion of the treating physician
Recent extended history of constant-recurrent substance abuse or another medical condition that might compromise safety or the successful completion of the study
Active drug or alcohol use or dependence that, in the opinion of the Site Investigator, would interfere with adherence to study protocol
Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study Inclusion Criteria Donor:
Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principle investigator (PI)
Any other serious medical condition that would make PA unsafe
Subjects with any significant psychological disturbance that, in the opinion of the Investigator, could impair the consent process or ability to complete self-assessment questionnaires.
Subjects with any other condition that would contraindicate participation, as determined by the Investigator.
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Participants who in the opinion of the principal investigator (PI) will be at higher risk of acetylsalicylic acid (ASA)-related complications
A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfil the inclusion criteria related to organ system function.
Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator or medical monitor, jeopardize the safety of a subject and/or their compliance with the protocol.
Medical comorbidities that in the opinion of the investigator limits the patient’s ability to complete this study
Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
Subject has significant uncontrolled medical condition within 6 months prior to enrollment, as determined by the investigator.
Subject has any condition that confounds the ability to interpret data from the study based on investigator´s judgment.
Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
Significant medical or psychiatric history which would make the participant a poor protocol candidate, in the opinion of the principal investigator, for any aspect of study participation including metformin, unsupervised exercise program or dietary behavior change
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
Psychiatric disorders or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
Any condition which in the Investigator’s opinion deems the subject an unsuitable candidate to receive study drug
Have any condition that in the opinion of the investigator would confound the efficacy, safety and tolerability assessments, such as oral thrush.
Any medical condition judged by the investigator to constitute a risk to safe participation
Any dermatological condition that in the opinion of the investigator will affect the absorption of the study medication, e.g. Atopic Dermatitis, etc.
Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion. Cohort A Only:
Intercurrent illness or other major medical condition or comorbid condition that might affect study participation (uncontrolled renal, pulmonary or hepatic dysfunction or infection)
Any condition which in the investigator’s opinion makes the patient unsuitable for the study participation
Medical history and concurrent disease:\r\n* Prior history of treated breast cancer\r\n* Any underlying medical or psychiatric conditions, which in the opinion of the investigator, will make performing the study intervention hazardous or obscure the interpretation of the results
A medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy, would compromise the patient’s ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
Subjects with other medical conditions deemed by the principal investigator (or associates) to make the subject ineligible for protocol procedures
Subjects with significant concurrent medical complications that in the judgment of the principal investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies
Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation
Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
Patient/participant has a medical condition which in the judgment of the investigator might make supine positioning for the duration of the scan unsafe, such as (but not limited to) congestive heart failure or significant pulmonary\r\ndisease
Any condition, medical or psychosocial, that in the opinion of the principal investigator would hinder compliance
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Any condition which in the investigator’s opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
Patients with psychiatric or other conditions rendering them incapable of participating in informed consent or the requirements of this protocol or other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures
Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
Subject is in acute unstable condition
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Inability to receive furosemide (Lasix) in the opinion of the treating investigator
Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
Any condition that, in the opinion of the principal investigator, would impair the patient’s ability to comply with study procedures
Any condition that, in the opinion of the principal investigator, would impair the patient’s ability to comply with study procedures
Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure
Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests)
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Inability to tolerate additional imaging time in the opinion of the investigator or treating physician
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological comorbidities that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
HEALTHY VOLUNTEER: Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by his participation in the study
HEALTHY VOLUNTEER: Any other condition precluding subject participation as per investigator judgment
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject’s ability to comply with the protocol requirements
Patients with vertebral lesions that, in the opinion of the principal investigator and the treating medical oncologist, pose an imminent risk for cord compression
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
Other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Any condition which, in the opinion of the investigator, might interfere with study objective
Any reason which, in the opinion of the investigator, adds additional risk to the patient
DONOR: Any condition which, in the opinion of the investigator, might interfere with study objective
Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study
Uncontrolled illness or comorbidity that in the judgment of the principal investigator (PI) would preclude participation in the study
It is determined by the investigator that the subject is clinically unsuitable for the study
Medical condition which requires pre-medication prior to dental visits/procedures
Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
Unstable medical condition, such as ischemic heart disease, or any other disease or medical condition that may place the patient at added risk during the study, as assessed by the Principal Investigator. A patient with a seizure disorder, focal or generalized, not adequately controlled by anti-convulsant therapy, and /or patient who have experienced an event of focal or generalized seizure within 7 days prior to screening will be considered neurologically unstable.
Other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator’s judgement
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
Any condition which in the Investigator’s opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g., significant cardiovascular conditions or allergies)
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient, limit the patient’s ability to complete the study, and/or compromise the objectives of the study
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject
Any additional medical condition, serious intercurrent illness or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study performance or interpretation
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
Any other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol
Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.
Subjects who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the subject's risk, interfere with protocol adherence, or affect the subject's ability to give informed consent are ineligible to participate in the study.
History or presence of an abnormal ECG that in the investigator's opinion is clinically meaningful.
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.
History or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other diseases, which, in the opinion of the investigator, may affect the subject's safety or interfere with the trial.
Any other condition which in the opinion of the investigator would interfere with successful completion of this clinical trial.
Any other local condition including bacterial superinfection which in the opinion of the investigator would interfere with the efficacy evaluation.
Significant co-morbid condition or disease which in the judgment of the principal investigator would place the patient at undue risk or interfere with the study
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study
Subject has any condition which makes the subject unsuitable for study participation.
Does the subject have any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirements
Investigator precludes participation for scientific reasons, for reasons of compliance (e.g., concurrent disease which could compromise the subject's study completion), or for reasons of the patient's safety
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug
Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures
Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.
Patient presenting with any condition which, based on the investigator's clinical judgment, would prevent the patient from completing all trial assessments and visits
Subjects with other medical conditions deemed by the principal investigator (or associates) to make the subject ineligible for protocol procedures
Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Presence of any additional medical condition such as inter-current illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
Any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
A serious underlying medical condition that would otherwise impair the patient’s ability to receive treatment and imaging studies
Any condition which, in the opinion of the investigator, would preclude participation in this trial
In the opinion of the investigator, the patient is felt not to be appropriate for the study
BIODISTRIBUTION COHORT: Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
DYNAMIC COHORT: Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive B-WARM
Serious underlying medical (including acute decompensated congestive heart failure) or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment; similarly, any unstable medical condition that, in the opinion of the treating physician or study investigators, would interfere with the study objectives
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive flaxseed
Presence of a comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol
Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data
Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator’s judgment, would interfere with participation in the trial
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study
A concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
Have serious preexisting medical conditions (left to the discretion of the investigator).
Any other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol
Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation, as determined by the principal investigator or by the attending palliative care physician
Any other criteria, in the opinion of the investigator that would make the subject unsuitable for study participation.
Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)
Any condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individual
Investigator feels participation is not in the best interest of the subject.
Life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, or put the study outcomes at risk.
Any subject for whom the investigator feels participation is not in the best interest of the subject.
Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data.
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
Any subject for whom the investigator feels participation is not in the best interest of the subject.
History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator or Medial Monitor
Any significant medical condition, that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study.
Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.
History or evidence of any psychiatric disorder, substance abuse or any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation
Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.
Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements