History of active primary immunodeficiency
History of leptomeningeal disease
Patients with history of John Cunningham (JC) virus identified in the cerebrospinal fluid (CSF) or previous history of PML will be excluded from the study
Known history of acute or chronic pancreatitis
Participants may not have had any prior history of hypertensive crisis or hypertensive encephalopathy
History of other previous cancer that would interfere with the determination of safety or efficacy
History of additional risk factors for torsade de pointes
Patients with a history of, or current grade 4 depression are not eligible
History or evidence of cirrhosis
History of more than 2 prior recurrences (including this recurrence) of GBM or AA
History of hypertensive crisis or hypertensive encephalopathy within 3 years
History of ventricular arrhythmia requiring medication
Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 75% or greater
No history of any prior stroke (hemorrhagic or ischemic)
Patients must not have any history of primary immunodeficiency
No history of cornea abnormalities
Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form
Patients must not have a history of immune-mediated pneumonitis or colitis that required interruption of therapy or treatment of steroids
Patients with a known history of congestive heart failure (CHF), cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications, or with a clinical history suggestive of the above must have an electrocardiography (EKG) and echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment
History of adrenal insufficiency or hypoaldosteronism
Patient must have no prior history of RCC that was resected with curative intent within the past 5 years
Patients with pre-existing significant central nervous system pathology that would preclude treatment with blinatumomab, including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement are not eligible; patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible; (patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved)
Patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded
History of progressive multifocal leukoencephalopathy (PML)
History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
Subject has a history of seizures within 12 months of Cycle 1 Day-2 or diagnosed neurological condition placing subject at the increased risk of seizures.
Active history of diverticulitis; note that diverticulosis is permitted
History of cerebrovascular disease
History or presence of sustained ventricular tachycardia
14. History of primary immunodeficiency;
History of exposure to the protocol specified doses of anthracyclines
Prior history of hypertensive crisis or hypertensive encephalopathy
Patients with history of positive dihydropyrimidine dehydrogenase (DPD) deficiency
Prior history of receiving pazopanib treatments
History of calcium oxalate stones
History of iron overload
History of infusion reactions to any component/excipient of PRS-343.
Significant history of medical conditions as listed in the protocol.
History of exposure to certain cumulative doses of anthracyclines
History of leptomeningeal disease;
Previous history of autologous or allogeneic-HCT
O2 saturation < 92% (on room air). 19. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden death.
Patients with a history of LVEF decline to below 50% during or after prior trastuzumab or other HER2 directed therapy
Patients with a history of intolerance to trastuzumab (i.e. a grade 3 or 4 infusion reaction) are excluded; Note: patients with a history of mild infusion reaction to trastuzumab who have previously been successfully re-challenged after an infusion reaction with or without prophylactic medication are allowed
Known history of myelodysplasia.
Evidence or history of other significant, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which would likely increase the risks of participating in the study.
Participant has a history of cholecystitis (subject with history of cholecystectomy will not be excluded), or has active gallbladder disease.
Patients with a known history of seizures must have well-controlled seizures and may not be receiving enzyme-inducing anti-convulsants
History of or high suspicion of Gilbert’s disease (safety run-in, Part B only)
History of progressive multifocal leukoencephalopathy (PML)
History of progressive multifocal leukoencephalopathy (PML)
Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions
History of known risks factors for bowel perforation
Subject who has a history of second primary cancer within the past 5 years, with the exception of:
Known history of acute or chronic pancreatitis
Any history of HIV-1 associated encephalopathy
History of grade III hemorrhagic cystitis due to prior cyclophosphamide chemotherapy
Bone metastases with prior history of pathologic fracture, lytic lesions requiring an orthopedic intervention, or not receiving bisphosphonates or denosumab
History of carcinomatous meningitis
History of acute pancreatitis within 1 year of study treatment or a history of chronic pancreatitis
History of gross hemoptysis.
Prior history of anaphylaxis with this product type
History of seizures
History of thromboembolism within the past 5 years, history of catheter-related thrombophlebitis or other clinically significant thrombophlebitis are excluded.
History of unprovoked venous thrombosis/thromboembolism
A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
History of acute pancreatitis within 1 year of study entry or history of chronic pancreatitis
Patients with a prior history of documented pancreatitis are not eligible
History of proximal urethral stricture requiring dilatation.
History of life threatening or recurrent thrombosis/embolism; patients may participate if they are on anticoagulation during the treatment
History of any drug allergies or significant adverse reactions to any of the components of SM-88.
Subjects with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins; or a history of prior acute hepatotoxicity attributable to phenytoin.
Known history of HBV or HCV infection.
History of any major disease that might interfere with safe protocol participation, as determined by the investigator
Have a history of prior radiotherapy to the whole pelvis.
Must have RAS mutation and microsatellite stability status results as part of medical history
Has a history of vasculitis.
Known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
HLA A2+ by deoxyribonucleic acid (DNA) sequence analysis (by history with documentation or as part of this study)
Subjects with history of osteoporosis
History of progressive multifocal leukoencephalopathy (PML).
History of progressive multifocal leukoencephalopathy (PML)
History of thrombocytopenia with complications
Patients with a history of external percutaneous transhepatic cholangiography catheter placement.
History of primary immunodeficiency
History of Wilson's disease.
History of hemochromatosis.
A history of renal failure (unless recovered for at least 6 months), lactic acidosis, recurrent or severe hypoglycemia, or significant chronic obstructive lung disease; patients will not be excluded for reversible episodes of elevated creatinine due to hypovolemia
A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Has a history of vasculitis.
Patients with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible
History of carcinomatous meningitis
Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML)
History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
History of splenectomy or planning to undergo splenectomy
History of pituitary or adrenal dysfunction
History of chronic pancreatitis.
History of pericarditis
History of receiving more than 2 classes of ADT
History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren’s disease
Any prior history of hypertensive crisis or hypertensive encephalopathy
Recent history of thyroiditis
Primary immunodeficiency
History of prior allogeneic HSCT
Known history of primary immunodeficiency
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
Presence or history of carcinomatous meningitis
History of uveal melanoma
History of allergies to any active or inactive ingredients of atezolizumab.
History of high grade disease
Subjects with a history of connective tissue disorders.
Subjects with a history of depression, anxiety, or psychotic disorders (due to tolcapone adverse event profile).
History of progressive multifocal leukoencephalopathy (PML)
Prior history of lactic acidosis
Any history of hemorrhagic stroke
History or clinical suspicion of neurofibromatosis
History of esophageal varices
Known history of splenomegaly
History of personal psoriasis.
History of tuberculosis or history of purified protein derivative (PPD) positivity
Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.
A history of chronic diarrhea, colitis, or intestinal perforation that in the opinion of the investigator precludes utilization of idelalisib
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assay
Patients who have a history of another primary malignancy from which the patient has been disease free for < 3 years at the time of enrollment, with the exceptions of: a patient with a familial cancer syndrome-associated NETs including MEN1, VHL, NF-1, and thymidylate synthetase (TS)
Diverticulitis (either active or history of) within the past 2 years; Note that diverticulosis is permitted
Have a history of thrombocytopenia with complications
Known family history of hereditary heart disease
No active tobacco use (> 10 years tobacco free interval, < 20 pack/year [pk/yr.] history)
History of vesicoureteral reflux or an indwelling urinary stent
History of coronary revascularization or ischemic symptoms
No history of bleeding problems; not taking aspirin or any medication that may affect erythrocyte biochemistry
History of sarcoidosis
History of hypercalcemia
History of coronary revascularization or ischemic symptoms
Patients with any of the following cardiovascular conditions: patent foramen ovale, prior history of bacterial endocarditis, any existing thrombus (either arterial or venous) as well as known history of DVT, permanent pacemakers, AICDs, LVADs, or other intravascular cardiac device, known AV malformations.
Individuals with known history of glucose 6 phosphate deficiency are excluded from the trial (possible issue with HCQ tolerance)
History of proximal urethral stricture requiring dilatation.
History of coronary revascularization or ischemic symptoms
History of proximal urethral stricture requiring dilatation
Patients with carcinomatosis meningitis or a history of ocular/uveal melanoma are excluded
Patients with a prior history of pulmonary toxicity due to medications (Ex: history of carmustine [BCNU] toxicity).
History of leptomeningeal carcinomatosis
History of neurological conditions that would confound assessment of treatment-emergent neuropathy
History of coronary revascularization or ischemic symptoms.
History of leptomeningeal carcinomatosis.
Subject has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa.
Patient has a history of pancreatitis
History of primary immunodeficiency.
History of refractory systemic infection.
Patients with history of more than one symptomatic oxalate stone
History of hypertriglyceridemia or hypercholesterolemia and currently on medication(s)
Prior history of hypertensive crisis, hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome (RPLS).
Primary immunodeficiency.
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
History of previous enrollment in Studies NCT02993523 or NCT03069352.
History of any renal calculi or hyperoxaluria or any other preexisting renal disorder
History of G6PD deficiency, hereditary spherocytosis or hemochromatosis
History of confirmed, corneal ulceration
History of active primary immunodeficiency.
History of Richter’s or prolymphocytic transformation
Has a history of primary immunodeficiency
Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmias or bradycardia, unless arrhythmia is controlled and after Cardiology has cleared patient to receive ONC201. Receiving therapeutic agents known to prolong QT interval will be excluded History of CHF, or MI or stroke in the last 3 months will be excluded.
History of coronary revascularization or ischemic symptoms
Known history of pituitary and/or adrenal disease (or dysfunction)
Present or history of progressive multifocal leukoencephalopathy (PML)
Has a known history of hypertensive crisis or hypertensive encephalopathy within 6 months prior to planned start of study drug
History of any inherited coagulation or platelet function, disorder or ITP, TTP, or HUS
Primary immunodeficiency
History of cirrhosis
Research participants does NOT have any known history of congestive heart failure (CHF) or cardiac symptoms consistent with NYHA classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an EKG and echocardiogram (ECHO) performed within 42 days prior to registration and as\r\nclinical indicated while on treatment
History of severe asthma or absolute requirement for chronic inhaled corticosteroid medications (subjects with a history of mild asthma that are on or can be switched to noncorticosteroid bronchodilator regimens are eligible)
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
History of hypertensive crisis or hypertensive encephalopathy within 3 years of the randomization
Has a history of, or is currently on, dialysis.
Primary immunodeficiency
Patients with a history of prior hematopoietic stem cell transplantation (HSCT), elevated conjugated serum bilirubin at study entry, uncontrolled systemic fungal, bacterial, or other infection, a history of hepatitis B or C infection or a history of cirrhosis
Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
Patients with a confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to signing informed consent are ineligible
History of immune-mediated pneumonitis
Autoimmune disease or history of primary immunodeficiency (excluding Hashimoto’s thyroiditis, vitiligo, or DM type I)
History of leptomeningeal carcinomatosis
History of known active primary immunodeficiency
History of leptomeningeal disease
Known history of pituitary or adrenal dysfunction
History of auto-immune disease (e.g., thyroiditis, lupus), except vitiligo
History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
History of multiple drug allergies or intolerance to subcutaneous injections
History of recurrent pancreatitis
History of leptomeningeal disease
Patients with a history of colitis.
History of prior immunotherapy within the last 3 years (immunotherapy allowed for lead-in cohort in castration resistant disease)
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
History of urethral stricture disease;
History of diseases with influence on bone metabolism, such as Paget’s disease, osteogenesis imperfecta, active primary or secondary hyperparathyroidism, and primary or secondary hyperthyroidism within 12 months prior to study entry
History of osteonecrosis of the jaw
History of treatment with known kinase inhibiting agents
History of gout
History of muscle cramps or restless legs
Known history of pituitary or adrenal dysfunction.
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of allergic response to BV-CHEP or its components or to any of the required prophylactic medications or reasonable alternatives
History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
History of keratitis;
No characteristics suggesting a potential higher risk of infection with intraprostatic injections:\r\n* Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study\r\n* Urine analysis positive for nitrites and leucocyte esterase; such patients could be considered for the study after treatment and resolution of the infection\r\n* Active proctitis\r\n* History of prostatic abscess\r\n* Taking immunosuppressive medication including systemic corticosteroids\r\n* Active hematologic malignancy
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
Subject has a history of non-central line related thrombosis (arterial or venous), more than one prior central-line related thrombosis or known coagulopathy.
Has a known prior history of viral hepatitis (B or C) as demonstrated by positive serology (presence of antigens) or have an uncontrolled infection requiring treatment
No history of medical condition resulting in nephrotic range proteinuria.
Patient has a history of interstitial cystitis
Lifetime pack-year history of < 10 years, currently non-smoking for at least 5 years.
History of claustrophobia.
History of leptomeningeal metastases
History of primary immunodeficiency
Patients must provide their personal smoking history prior to registration; patients cannot have a cumulative personal smoking history that exceeds 10 pack-years\r\n* Number of pack-years = (frequency of smoking [number of cigarettes per day] x duration of cigarette smoking [years]) / 20\r\n* Note: Twenty cigarettes is considered equivalent to one pack; cigar and pipe tobacco consumption is not included in calculating lifetime pack-years
History of seizures
History of primary immunodeficiency
History of ventilator support related to lung injury (e.g., pneumonia, hemorrhagic pneumonitis, capillary leakage)
Any history of allografts
History of pre-existing immunodeficiency disorder, autoimmune condition, or chronic infection
History of active primary immunodeficiency
History of leptomeningeal carcinomatosis
History of primary immunodeficiency.
History of leptomeningeal carcinomatosis.
History of active primary immunodeficiency
History of leptomeningeal carcinomatosis
History of coronary revascularization or ischemic symptoms
History of major implant(s) or device(s), including but not limited to:\r\n* Prosthetic heart valve(s).\r\n* Artificial joints and prosthetics placed =< 12 months prior to treatment initiation.\r\n* Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed.
(Bevacizumab-related exclusion) Prior history of hypertensive crisis or hypertensive encephalopathy
History of primary immunodeficiency
Creatinine > 1.5 or history of renal disease preventing use of ZA
History of primary immunodeficiency
Has history of osteonecrosis of the jaw
Subject has a history of coagulopathies or hematological disorders
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
History of primary immunodeficiency
Subjects must not have history of scleroderma or lupus erythematosus with either cutaneous manifestation or requiring active treatment
Prior history of esophageal perforation
Prior history of hypertensive crisis or hypertensive encephalopathy
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
Patients with known history of serous retinopathy will not be eligible
Patient with a history of genetic prothrombotic state
Patients who are known to have a history of or a finding of corneal epitheliopathy at pre-study are excluded
History of primary immunodeficiency
History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
Patients with prior or current history of digoxin exposure
Patient with history of prior exposure to decitabine
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
History of neurological conditions that would confound assessment of treatment-emergent neuropathy
History of VOD
Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity
Patients who have a history scleroderma or other active connective tissue disease
Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
Deferral of donors that:\r\n* Have traveled to active Zika virus zones \r\n* Are at potential risk of transmissible spongiform encephalopathy (TSE), including Creutzfeldt–Jakob disease (CJD), based on family and travel history
History of primary immunodeficiency
History of vesicoureteral reflux.
Patients known to be colonized with multi-drug resistant organisms or with history of infection with multi-drug resistant organisms; patients with history of infection with extended-spectrum beta-lactamase producing organism
Patients with history of lactic or any other metabolic acidosis
History of pancreatitis
No history of seizures, encephalitis, or multiple sclerosis
No known prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Known previous history of sensitivity to talimogene laherparepvec or any of its components to be administered during dosing (e.g. sorbitol, myo-inositol)
Prior history of hypertensive crisis or hypertensive encephalopathy
History of intolerance to somatostatin analogues
Subjects who have unknown transfusion history
History of primary immunodeficiency.
Prior history of hypertensive crisis or hypertensive encephalopathy
PRE-SCREENING: No history of keratitis or corneal disease
History of clinically severe (e.g., requires chronic immunosuppressive therapy, [e.g., cyclosporine A, tacrolimus]) autoimmune disease (e.g., ulcerative colitis, lupus), or history of organ transplant
History of severe asthma, presently on chronic medications (a history of mild asthma requiring inhaled steroids only is eligible)
History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7
Participants with a history of progressive multifocal leukoencephalopathy
Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillators [ICD] is indicated but not placed (participants who do have a pacemaker/ICD are allowed on study)
History or presence of a 2nd autoimmune disease requiring immunosuppressive therapy that has substantial risk of immunosuppressive treatment beyond transplant with the following exceptions:\r\n* History and/or presence of Sjogren's Syndrome is allowed\r\n* Stable myositis (A history of myositis that is clinically stable as defined by lack of progressive proximal muscle weakness and a stable or decreasing creatine phosphokinase [CPK] < 3 x ULN) is allowed\r\n* The presence of anti-double stranded (ds)-deoxyribonucleic acid (DNA) without clinical systemic lupus erythematosus in a patient with a diagnosis of otherwise \pure\ SSc is allowed\r\n* Concomitant rheumatoid arthritis without extra-articular disease characteristic of rheumatoid arthritis is allowed
Evidence of myelodysplasia (MDS); subjects with history of receiving any prior chemotherapy and/or radiotherapy for the treatment of malignant disease, history of greater than 2 months total prior cyclophosphamide for any condition (regardless of dose and route) and/or subjects presenting with abnormal peripheral blood counts require unilateral bone marrow aspiration for pathology, flow cytometry, cytogenetics, and fluorescence in situ hybridization (FISH) MDS panel (per institutional profile) to rule out MDS
No known history of dihydropyrimidine dehydrogenase deficiency
Patients with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
History of hypertensive crisis or hypertensive encephalopathy within 3 years prior to registration
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of primary immunodeficiency
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of treatment with ibrutinib or blinatumomab
A history of metal in the head or eyes
Patients with a previous history of neurological complications due to polyoma virus (PV) infection
Patients with known history of agammaglobulinemia
Has a history of primary immunodeficiency
History of acute diverticulitis within the last 6 months, or current chronic diarrhea
A history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b
Has history of bipolar disorder or major depression
Has history of not tolerating interferon treatment
Subjects must have no prior history of veno-occlusive disease (VOD)
Gastrointestinal tract disease or defect or previous history of colitis.
Known history of Wilson’s disease or a copper deficiency
History of or current relevant central nervous system pathology such as epilepsy, recurrent seizures, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome or psychosis.
History of seizures
History of seizures
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
Active smoking or a cumulative pack year history of > 20 pack years, active smoking is (defined as >= 1 cigarette per day) within the last 5 years
History of non-transfusional hemosiderosis
History of radiation proctitis (for lead-in CRPC cohort only)
Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
Patients with a history of intolerance to Das or for whom Das might not be appropriate
History or presence of sustained bradycardia (less than or equal to 60 beats per minute [BPM]) or history of symptomatic bradycardia, left bundle branch block, cardiac pacemaker or significant atrial tachyarrhythmias, as defined by the need for treatment
Previous history of grade 3 or worse drug-induced QTc prolongation requiring treatment withdrawal
History of refractory systemic infection
History of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
History of primary immunodeficiency
History of seizures in the past 3 years
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.
Patients with history of lactic or any other metabolic acidosis
History of coronary revascularization or ischemic symptoms
History of stroke within the last 5-years
History of peptic ulcer disease requiring treatment within the last 5-years
History of glucose-6-phosphate dehydrogenase deficiency
History of coronary revascularization or ischemic symptoms
History of primary immunodeficiency
History of impaired adrenal gland function (eg, Addison's disease, Cushing's syndrome).
Previous history of difficulty swallowing capsules.
History of progressive multifocal leukoencephalopathy
Diverticulitis either active or history of within the past 2 years; note that diverticulosis is permitted
History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility, for example, gastroparesis, history of extensive abdominal surgery
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
History of coronary revascularization or ischemic symptoms
Pulmonary function testing in patients with:\r\n* A prolonged history of cigarette smoking (20 pk/yr of smoking within the past two years)\r\n* Symptoms of respiratory dysfunction
Have a known history of pituitary or adrenal dysfunction
History of hemoptysis (defined as > 1/2 tablespoon [tsp] of bright red blood per day)
History of active primary immunodeficiency
Prior history of pseudoprogression or radionecrosis from cranial radiotherapy
The patient has a history of uncontrolled hereditary or acquired thrombotic disorder
Known history of osteoporosis
Known history of macular edema
Known history of ABL1-domain mutation that predicts resistance to the discontinued TKI
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product
History of hemochromatosis or family member with hemochromatosis
History and/or current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc unless the lead investigator obtains approval from Novartis
History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis; history of other organic brain syndrome that in the opinion of the PI or designee is a contraindication to lymphodepleting chemotherapy, JCAR014 infusion or durvalumab infusion
Has a history of any of conditions that would contraindicate administration of an OC
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of prior irradiation to the area to be treated
History of tuberculosis or history of purified protein derivative (PPD) positivity
History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma not requiring corticosteroid therapy are eligible)
Known history of plasma cortisol and adrenocorticotropic hormone (ACTH) levels consistent with adrenal failure
Patients with previous history of radiosurgery, brachytherapy, Gliadel implantation, or radiolabeled monoclonal antibodies
history of acute coronary syndromes (including unstable angina)
History of grade 4 rash associated with thalidomide treatment
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
Patients with history of splenectomy
History of renal or hepatic disease, including history of hepatitis B or C
Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
History of coronary revascularization or ischemic symptoms
Patients with a history of PR prolongation or atrioventricular (AV) block
Patients with a history of prior therapy with paclitaxel and/or carboplatin
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of pneumonitis requiring hospitalization or systemic immune suppressive therapy
Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
No history of prior radiotherapy overlapping with high dose region of planned SABR course
No prior history of lung resection on ipsilateral side
No prior history of multifocal adenocarcinoma in situ (ie, classic or pure bronchioloalveolar carcinoma)
History or presence of bradydysrhythmia or conduction abnormalities
History or presence of cardia arrest or unexplained syncope
History of Paget’s disease
Subjects must not have a history of neurodegenerative or central nervous system movement disorder
Patients with history of previous immunomodulatory therapy (not including lenalidomide or thalidomide)
Confirmed history of CD19 positivity by flow cytometry for malignant cells
History of carcinomatous meningitis
History of or current diagnosis of progressive multifocal leukoencephalopathy (PML)
History of primary immunodeficiency
Subject has history of major immunologic reaction to any Immunoglobulin G (IgG) containing agent.
Patients with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment
History of cerebrovascular disease
Prior history of rectal resection
History of active connective tissue disease (scleroderma)
Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance
History of seizures
Active or history of diverticulitis; diverticulosis is permitted
History of arterial thromboembolic event
History of prior or current splenectomy or splenic irradiation
Any prior history of hypertensive crisis or hypertensive encephalopathy
History of
Subjects with a history of seizures
History of familial cardiomyopathy
History of infiltrative cardiomyopathy or restrictive cardiomyopathy
Medical history of vasculitis or lupus erythematosus
Prior history of receiving afatinib
History of rectal fistula
If history of depression or psychiatric illness, has to be well controlled with antidepressants and/or under psychiatrist/ psychologist care
A history of prior radiotherapy that precludes delivery of hypofractionated radiotherapy
History of carcinomatous meningitis
Patients with a history of other malignancies, except:
History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
History of acute pancreatitis within one year of study or history of chronic pancreatitis
Patients with history of atrial arrhythmia (requiring any anti-arrhythmic therapy) or patients with any history of ventricular arrhythmia are excluded
Patients with history of pneumonectomy
History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
History of seizures, movement disorders or cerebrovascular accident within the past 1 year prior to cycle 1 day 1
Known history of confirmed primary immunodeficiency
Have a history of neurological illness or closed head injury
A known history of intolerance to ketoconazole
A known history of intolerance to vincristine
History of non-compliance
City of Hope (COH) pathology review confirms that research participant’s diagnostic material is consistent with history of ALL with history of recurrence/progression/minimal residual disease (MRD) following prior therapy; additionally, CD19 positivity must be documented in a pathology report; however, it is not a requirement that the CD19 testing be performed by a COH pathologist; patients in second complete remission (CR2) or higher with history of CD19+ ALL on previous bone marrow biopsy are also eligible for the study
Subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than BCC/squamous cell skin cancers)
Subjects with a history of keloids or excessive scarring
Prior history of hypertensive crisis or hypertensive encephalopathy
Less than or equal to 10 pack years of tobacco history
Prior history of a thromboembolic event within the last two years and not currently on systemic anticoagulation
Patients with a history of asthma will be excluded
History of gastric or duodenal ulcers or untreated hyperacidity syndromes
No history of chronic diarrhea
Significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
Patients who have a history of listeriosis prior ADXS11-001 therapy
History of kidney stones
History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator’s discretion
History of coronary revascularization or ischemic symptoms
Any medical history, concurrent disease or concomitant medication which could reasonably predispose the patient to renal insufficiency while on study treatment
History or behavior that would, in the investigator’s judgment, prohibit compliance for the duration of the study
History of arrhythmia requiring pharmacological or electrical treatment
Any prior history of hypertensive crisis or hypertensive encephalopathy
History of sustained ventricular tachycardia
Prior myocardial infraction (MI) ascertained from medical history and review of systems
Patients with a history of hepatitis C, but have a negative viral load, are eligible
History of priapism
Known history of retinitis pigmentosa
Subjects must not have a history of any significant renal or hepatic disease requiring ongoing medical therapy or clinical intervention
Patients must not have a history of any immune system disorder, or laboratory abnormality or any condition that could potentially alter immune function
History of anakinra use
Previous history of splenectomy or whole spleen radiation
Any of the following concurrent severe and/or uncontrolled medical conditions:\r\n* Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication\r\n* Angina pectoris\r\n* History of congestive heart failure =< 3 months, unless ejection fraction > 40%\r\n* Myocardial infarction =< 6 months prior to registration\r\n* Cardiac arrhythmia\r\n* Poorly controlled diabetes\r\n* Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung\r\n* Active or recent history of hemoptysis; if hemoptysis has resolved with measures such as palliative radiation therapy (e.g. 3000 cGy over 10 fractions), arteriographic embolization or endobronchial interventions (e.g. photodynamic therapy, brachytherapy), etc. for > 14 days, patients may be considered for participation in this study\r\n* >= Grade 2 hypertriglyceridemia\r\n* >= Grade 2 hypercholesterolemia\r\n* Any illness that in the opinion of the investigator would compromise the ability of the patient to participate safely in the clinical trial
Patients with a history of documented human anti-globulin antibodies.
History of biliary colic attack
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Family history of toxic epidermal necrolysis
COHORTS 1 AND 2: HEALTHY VOLUNTEERS: History of AD and asthma
COHORT 3: ATOPIC DERMATITIS PATIENTS: Family history of toxic epidermal necrolysis
Patients with history of bleeding disorder or with history of spontaneous haemorrhage tumour
History of coronary revascularization or ischemic symptoms
Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's)
History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
History of pituitary or adrenal dysfunction
Any history of ventricular arrhythmia; or
Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
Prior history of hypertensive encephalopathy
History of sensitivity to, or history of conditions that are known to cause sensitivity to, radiation therapy
Overt psychosis, mental disability, otherwise incompetent to give informed consent, or history of non-compliance
A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
History of an active connective tissue disorder
DONOR: History of hypertension that is not controlled by medication, stroke, or severe heart disease (donors with symptomatic angina will be excluded); donors with a history of coronary artery bypass grafting or angioplasty who are symptom free will receive a cardiology evaluation and be considered on a case-by-case basis
History of seizures
Any prior history of hypertensive crisis or hypertensive encephalopathy
History of proximal urethral stricture requiring dilatation
History or evidence of a physician-diagnosed chronic or recurrent inflammatory skin disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) at the proposed site of administration in the past 5 years.
Patients with a history of keloid formation ( ID delivery group only)
A history of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous
Documented history of nephrolithiasis within the past 5 years
History and/or clinical evidence of distant metastases (M1)
History of pancreatitis
History of valproic acid (VPA) use
Patients with a history of embolic events (e.g. TIA) from arrhythmia or peripheral arterial disease or of recent MI whether or not treated with anti-platelet drugs
Patients with a history of coronary artery disease with angina pectoris, or a history of congestive heart failure will not be eligible to receive DA-EPOCH-R chemotherapy
History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.
History of primary immunodeficiency
History of active primary immunodeficiency
No history of a coagulation disorder
Subjects with a history of hepatitis of any etiology or hepatic insufficiency
History of splenectomy
History of narcolepsy or any neurological condition which may impair consciousness
History of sensitivity to any of the study medications, or metabolite thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation CARDIAC MAGNETIC RESONANCE (CMR) SCANNING
History of claustrophobia 99m^TC-PYP OR 99mTC-DPD BONE TRACER RADIOSCINTOGRAPHY
Presence or history of a malignant disease other than the study related cancer
Clinical evidence or known history of cardiopulmonary disease
Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment.
A history of biopsy-confirmed exclusive radionecrosis after initial GBM therapy
Prior history of receiving pazopanib treatments
History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
History of significant neurologic or psychiatric disorders including dementia or seizures
Patients who have a smoking history of > 10 pack-years
History of seizures or extrapyramidal symptoms
History of continuous daily use of PPI more than 1 year prior to consent
History of bipolar disorder.
History of diagnosis of neurogenic bladder requiring intermittent catheterization.
History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
Known history of allergies or sensitivities to gentamicin.
History of or current immunodeficiency disease or prior treatment compromising immune function
Subject has history of primary immunodeficiency
A history of thromboembolic disorder
History of prior mastectomy
Patients with history of a photosensitivity disease, such as porphyria cutanea tarda
Confirmed history of CD19-positivity by flow cytometry for malignant cells.
Part 2: history of glaucoma
History of peritonitis or diverticulitis
History of and or medical condition (e.g. diverticular disease; aneurysm) that predisposes to risk of major hemorrhage
History of leptomeningeal carcinomatosis
History of active primary immunodeficiency
Exclusion criteria based on organ function or medical history:\r\n* History of clinically significant cardiac or pulmonary dysfunction including the following:\r\n** Inadequately controlled hypertension (that is defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg that is treated or untreated)\r\n** History of myocardial infarction within 6 months prior to first dose of study drug in cycle\r\n** Prior history of hypertensive crisis or hypertensive encephalopathy\r\n** History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or non-infectious pneuomonitis requiring steroids\r\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of cycle 1 day 1\r\n* History of stroke or transient ischemic attack within 6 months prior to cycle 1 day 1\r\n* Serious non-healing wound, active ulcer or untreated bone fracture\r\n* History of abdominal fistula or gastrointestinal perforation within 6 months prior to cycle 1 day 1\r\n* History of hemoptysis (?one teaspoon of bright red blood per episode), or any other serious hemorrhage or at risk of bleeding (gastrointestinal history of bleeds, gastrointestinal ulcers, etc.). INR > 1.5 and aPTT > 1.5 x ULN within 7 days prior to cycle 1 day 1. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding\r\n* Life expectancy of < 12 weeks\r\n* Any previous venous thromboembolism >= grade 3\r\n* Proteinuria at screening as demonstrated by urine dipstick >= 2+ or 24-hour. proteinuria > 1.0 g\r\n* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal\r\n* Uncontrolled serious medical or psychiatric illness\r\n* Pregnant or lactating, or intending to become pregnant during the study. Women who are not post-menopausal (>= 12 continuous months of amenorrhea with no identified cause other than menopause) or surgically sterile must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1
Patients with known history of G6PD deficiency
History of active coronary or ischemic symptoms
History of prior bowel fistula, ulcerations, or perforations
History of primary immunodeficiency.
History of progressive multifocal leukoencephalopathy (PML)
History of tuberculosis or positive purified protein derivative (PPD) test
History of primary immunodeficiency
History of leptomeningeal carcinomatosis or uncontrolled seizures
Suicidal ideation or history of suicide attempt
History of familial cardiomyopathy
History of infiltrative cardiomyopathy or restrictive cardiomyopathy
Participants with a history of cranial nerve palsy
History or current evidence of hyperthyroidism that would increase metabolism of itraconazole
History of arterial thromboembolic events
History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
History of auto-immune disease per physician discretion
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
History of pituitary or adrenal dysfunction
Known history of pancreatitis
History or presence of an abnormal electrocardiogram (ECG)
History of leptomeningeal disease
Patients with any prior history of SOS irrespective of severity
History of primary immunodeficiency
History of tuberculosis or history of tuberculin purified protein derivative (PPD) positivity
Patients who have a history of noninfectious (toxic, autoimmune) hepatitis or alcoholism
Patients with a lifetime history of porphyria or psoriasis
TREATMENT: Patients with a history of seizures are not eligible to receive veliparib, but patients with a history of CNS metastases who have received treatment and who either have not had seizures or have been on stable doses of anti-seizure medicine and had no seizures for >= 4 weeks will be eligible for other study agents; enzyme inducing anticonvulsants are contraindicated
History of tuberculosis or purified protein derivative (PPD) skin test positivity
Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation
Known history of acute or chronic pancreatitis
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of partial or total gastrectomy
Patients with a history of platelet alloimmunization
History of diverticulitis or pancreatitis within 12 weeks of registration
Prior history of hypertensive crisis or hypertensive encephalopathy
History of progressive multifocal leukoencephalopathy
History of tuberculosis or history of purified protein derivative (PPD) positivity
Patients with a history of venous or arterial thrombosis personally before the age of 40 years unless associated with a central line
History of a light-sensitive cutaneous disease
For participants on the BKM120 cohort only: \r\n* Any patient with a history of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, a history of suicide attempt or ideation, or homicide/homicidal ideation as judged by the investigator and/or based on recent psychiatric assessment will not qualify for study participation\r\n* >= CTCAE grade 3 anxiety at the time of study entry regardless of whether the anxiety is being treated with medications\r\n* Patients with the following mood disorders as judged by the investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n** Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n** >= CTCAE grade 3 anxiety\r\n** Meets the cut-off score of >= 10 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD)-7 mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
Previous history of intravesical therapy allowed
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others); ), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM]- IV) are not eligible; patients who have a history of major depression that is controlled with chronic oral therapy are eligible provided they have no history of inpatient hospitalization, history of documented suicide attempt or ideations, and are managed with one anti-depressant which has not required dose adjustment in 6 weeks; patients with a history of depression who would otherwise be eligible should be evaluated by a mental health professional prior to enrollment if there is any uncertainty regarding the status of their mental health; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug
Subject with history of acute within one year of study entry or past medical history of chronic pancreatitis
History of pancreatitis
Patients must provide their personal smoking history prior to registration; the lifetime cumulative history cannot exceed 10 pack-years; the following formula is used to calculate the pack-years during the periods of smoking in the patient’s life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history\r\n* Number of pack-years = (frequency of smoking [number of cigarettes per day] x duration of cigarette smoking [years])/20 \r\n* Note: twenty cigarettes is considered equivalent to one pack; the effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined; cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years; marijuana consumption is likewise not considered in this calculation; there is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease; investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone
Patients with a history of chronic kidney disease or lactic acidosis
History of spontaneous pneumothorax
History of seizures
Prior history of SCCHN
Altered immune function, including immunodeficiency or history of immunodeficiency; eczema; history of eczema, or other eczematoid skin disorders; or those with acute, chronic or exfoliative skin conditions (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
History of >= 10 pack-years of smoking cigarettes
A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
Patients with a history of pancreatitis, cholelithiasis, alcoholism, or fasting hypertriglyceridemia (> 2 x ULN)
History of prior IPHC/HIPEC
History of prior HIPEC
Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible
History of cholecystitis without cholecystectomy
History of syncope or family history of idiopathic sudden death
DONOR: History of medical illness that in the estimation of the PI or DTM/NMDP physician poses prohibitive risk to donation including, but not limited to, stroke, hypertension that is not controlled with medication, or heart disease; individuals with symptomatic angina or a history of coronary bypass grafting or angioplasty will not be eligible
Any prior history of hypertensive crisis or hypertensive encephalopathy
History of psychiatric disorder (e.g. depression; suicidal ideation; psychosis)
History of psychiatric disorder (e.g. depression)
History of uveal melanoma
Subjects must not have primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states or history of other malignancy within the past 3 years.
History of progressive multifocal leukoencephalopathy (PML)
History of known leptomeningeal involvement (lumbar puncture not required)
Patients with a known history of primary and secondary adrenal insufficiency are not eligible
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with a history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases or a history of stroke within 5 years of the first date of treatment on this study
History of:
Subject has a prior history of malignancies other than AML unless the subject has been free of the disease for ? 5 years from first dose of lenalidomide.
Subject has a history of well-documented prior veno-occlusive disease (VOD).
They have a history of a venous or arterial thrombosis that was not associated to a central line.
Known history of hereditary hemorrhagic telangiectasia (HHT).
History of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to first dose of pazopanib
Subject has history of Myeloproliferative Neoplasm (MPN).
Subject has a history of other malignancies .prior to study entry, with the exception of:
History of lung inflammation or disease.
Patient must have no history of venous thrombosis within 12 weeks of randomization
Patient must not have history of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to randomization
Documented history of a cerebral vascular event
History of progressive multifocal leukoencephalopathy (PML)
Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
Patients with a history of ipsilateral DCIS are eligible
History of coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study
History of hepatic encephalopathy
Inclusion Criteria:\n\n        Eligibility is determined prior to leukapheresis. Subjects must satisfy the following\n        criteria to be enrolled in the study:\n\n          1. Subject is ? 18 years of age at the time of signing the informed consent form (ICF).\n\n          2. Documented diagnosis of multiple myeloma\n\n               -  Must have received at least 3 prior MM treatment regimens. Note: induction with\n                  or without hematopoietic stem cell transplant and with or without maintenance\n                  therapy is considered a single regimen.\n\n               -  Must have undergone at least 2 consecutive cycles of treatment for each regimen,\n                  unless PD was the best response to the regimen.\n\n               -  Must have received a proteasome inhibitor, an immunomodulatory agent and an\n                  anti-CD38 antibody.\n\n               -  Must be refractory to the last treatment regimen.\n\n          3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n\n          4. Subjects must have measurable disease, including at least one of the criteria below:\n\n               -  Serum M-protein greater or equal to 1.0 g/dL\n\n               -  Urine M-protein greater or equal to 200 mg/24 h\n\n               -  Serum free light chain (FLC) assay: involved FLC level greater or equal to 10\n                  mg/dL (100 mg/L) provided serum FLC ratio is abnormal\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subjects with known central nervous system involvement with myeloma.\n\n          2. History or presence of clinically relevant central nervous system (CNS) pathology.\n\n          3. Subjects with active or history of plasma cell leukemia.\n\n          4. Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence\n             of measurable disease\n\n          5. Inadequate organ function\n\n          6. Ongoing treatment with chronic immunosuppressants\n\n          7. Previous history of an allogeneic hematopoietic stem cell transplantation or treatment\n             with any gene therapy-based therapeutic for cancer or investigational cellular therapy\n             for cancer or BCMA targeted therapy\n\n          8. Evidence of human immunodeficiency virus (HIV) infection.\n\n          9. Seropositive for and with evidence of active viral infection with hepatitis B virus\n             (HBV)\n\n         10. Seropositive for and with evidence of active viral infection with hepatitis B virus\n             (HBV) and Hepatitis C virus (HCV)\n\n         11. Subjects with a history of class III or IV congestive heart failure (CHF) or severe\n             non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial\n             infarction, or ventricular arrhythmia within the previous 6 months.\n\n         12. Subjects with second malignancies in addition to myeloma if the second malignancy has\n             required therapy in the last 3 years or is not in complete remission\n\n         13. Pregnant or lactating women.\n\n         14. Subject with known hypersensitivity to any component of bb2121 productThe presence of\n             any of the following will exclude a subject from enrollment:\n\n        1. Subjects with known central nervous system involvement with myeloma. 2. History or\n        presence of clinically relevant central nervous system (CNS) pathology.\n\n        3. Subjects with active or history of plasma cell leukemia. 4. Subjects with solitary\n        plasmacytomas or non-secretory myeloma without other evidence of measurable disease 5.\n        Inadequate organ function 6. Ongoing treatment with chronic immunosuppressants 7. Previous\n        history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene\n        therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA\n        targeted therapy 8. Evidence of human immunodeficiency virus (HIV) infection. 9.\n        Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)\n        and Hepatitis C virus (HCV) 10. Subjects with a history of class III or IV congestive heart\n        failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina,\n        myocardial infarction, or ventricular arrhythmia within the previous 6 months. 11. Subjects\n        with second malignancies in addition to myeloma if the second malignancy has required\n        therapy in the last 3 years or is not in complete remission 12. Pregnant or lactating\n        women. 13 Subject with known hypersensitivity to any component of bb2121 product,\n        cyclophosphamide, fludarabine, or tocilizumab.
History of leptomeningeal disease
Known history of MDS.
No evidence of any systemic autoimmune disease (e.g. Hashimoto’s thyroiditis) and/or any history of primary or secondary immunodeficiency, and no immunosuppressant therapy (with the exception of dexamethasone as noted below) for any reason
Appropriate treatment history for histological entity.
Patients must not have a history of seizures
History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)
History of Parkinson's disease or multiple sclerosis
Patients must not have any history of primary immunodeficiency
Any history of hepatic encephalopathy
History of primary immunodeficiency
History of high grade esophageal or gastric varices
History of listeriosis or previous treatment with a listeria-based immunotherapy
History of leptomeningeal disease
Subject must not have primary ocular or mucosal melanoma, or history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia).
History of cerebral vascular accident or stroke within the previous 2 years
Have a prior history of a documented hemolytic event.
History of exposure to the cumulative doses of anthracyclines
Prior history of malignancies, (except MDS for AML subjects), unless the subject has been free of the disease for ? 2 years. However, subjects with the following history/concurrent conditions are allowed:
History of primary immunodeficiency.
Has active cerebral/meningeal disease, active cytomegalovirus (CMV) colitis, or signs and symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML.
Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)
Patients are excluded if they have any prior history of hypertensive crisis or hypertensive encephalopathy
History of histologically documented r/r Grades 1 to 3a FL, or r/r DLBCL
Any history of hepatic encephalopathy
Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
Patients must not have prior history of desquamating rash from thalidomide at time of study entry
Patients must not have a history of thrombo-embolic events within 3 years prior to study randomization
History of progressive multifocal leukoencephalopathy
Known history of positive serum human ADA.
Prior history of invasive adenocarcinoma of colon or rectum.
Know history of allografts (including corneal transplant).
SUB-PROTOCOL AIM A: Patients with a history of alcoholism, drug addiction or psychotic disorders
History of resistance to lenalidomide or response duration of <1 year
History of progressive multifocal leukoencephalopathy
No history of uncontrollable supraventricular arrhythmias
a history of \double/triple hit\ genetics
Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ?5 years prior to screening.
History of carcinomatosis meningitis
History of auto-immune disease
Any prior history of hypertensive crisis or hypertensive encephalopathy.
History of other active malignancies.
No history of known human anti-chimeric antibody (HACA) positivity; this does not have to be checked prior to enrollment unless clinically indicated
Present or history of progressive multifocal leukoencephalopathy (PML)
History of pancreatitis or chronic pancreatitis.
Prior history of hypertensive crisis or hypertensive encephalopathy
Patients with history of thrombophlebitis within the past 2 years or ongoing thromboembolic disorders
History of high grade esophageal or gastric varices
Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin <10 g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.
History or current evidence of
Have a history of uncontrolled hereditary or acquired thrombotic disorder.
History of prior immunodeficiency
Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
History of progressive multifocal leukoencephalopathy
No prior history of immune checkpoint modulator therapy
Echocardiogram (ECHO) cardiogram and cardiology consultation required within 7 days prior to registration for patients with a history of congestive heart failure or cardiovascular disease or history of exposure to cardiotoxic agents who are not already excluded
History of Wilson’s disease or other copper-metabolism disorder
History of or current immunodeficiency disease, splenectomy or splenic irradiation
History of meningococcal disease
History and/or current evidence of uncontrolled endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc
Prior history of whole brain radiotherapy (only applicable for AZD3759 BM expansion)
History of immunization with LL37
History of or suspected Gilbert’s disease (testing not required if presence is not suspected)
History of acute diverticulitis, or current chronic diarrhea
History of adrenal insufficiency (including subjects using replacement therapy)
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
Patient must not have active systemic lupus erythematosus, or any history of active scleroderma, or dermatomyositis with active rash
Active systemic lupus erythematosus, or any history of active scleroderma, dermatomyositis with active rash
History of or plan for splenectomy or splenic irradiation
There is no specific platelet and absolute neutrophil count that will exclude patients from this study given the natural history of AML
History of limb perfusion therapy
History of radiotherapy for the treatment of melanoma
Family history of inherited colon cancer syndromes
Known personal history of >3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) >2 centimeters (cm) in size
History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions
History of local and/or regional and/or distant melanoma recurrence
History or current radiographic or pathologic evidence of distant metastases
Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system.
History of splenectomy
History of salvage prostatectomy
The patient has a history of pancreatitis.
For NSCLC, patients must have a minimum of a 10 pack-year smoking history.
History of primary idiopathic myelofibrosis
History of known risks factors for bowel perforation
Primary immunodeficiency
History of a calcium/phosphate homeostasis disorder
History and/or current evidence of ectopic mineralization/calcification
Known history of acute or chronic pancreatitis
Current history of neoplasm other than the entry diagnosis. Exceptions are:
Eligibility for pheresis: (Turnstile 1) Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease. A diagnosis of uveal melanoma can be made clinically without primary tissue evaluation, based on history and records. A prior history of brachytherapy to the eye is sufficient clinical support for a diagnosis of uveal melanoma.
History of meningococcal disease
History of other malignancies, unless disease-free for ? 5 years.
Any patient with a history of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, a history of suicide attempt or ideation, or homicide/homicidal ideation as judged by the investigator and/or based on recent psychiatric assessment may not participate in this study without discussion with and agreement of the study principal investigator (PI)
History of hypertensive crisis or hypertensive encephalopathy
History or recent diagnosis of demyelinating disease
History of other carcinoma =< 3 years; exception: if risk of recurrence is known to be under 5% at time of randomization
Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation
History of primary immunodeficiency
Diverticulitis (either active or history of) within the past 2 years; note that diverticulosis is permitted
History of primary immunodeficiency
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, homicidal ideation (e.g. risk of doing harm to self or others)
History of transformation of indolent disease to DLBCL
History of prior immunotherapy within the last 3 years
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
History of Raynaud’s disease, cryoglobulinemia
Subjects who have a history or current evidence of malignant biliary obstruction requiring biliary stent.
History of leptomeningeal carcinomatosis
History of leptomeningeal carcinomatosis
Patient has a history of interstitial cystitis.
History of median sternotomy
Patients with a remote history of asthma or active mild asthma may participate.
History of topotecan treatment for SCLC
History of adrenal insufficiency
Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
Has a history of epilepsy, depression or other psychiatric disorders.
History of active primary immunodeficiency
History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity)
History of
Known prior history of tuberculosis or positive purified protein derivative (PPD) test result
Prior history of any viral-based therapy
Prior history of lactic acidosis or metabolic acidosis
Family history consistent with thrombophilia or hypofibrinolysis
History of or current amyloidosis
History of previous or concurrent (i.e., second primary) invasive melanoma.
History of or current pheochromocytoma
History of contact dermatitis to clobetasol propionate or similarly fluorinated steroids or other steroids with the propionate ester
Participants may not have had any prior history of hypertensive crisis or hypertensive encephalopathy
Has a history of hypertensive crisis or hypertensive encephalopathy
Any history of second- or third-degree heart block. (Patients with pacemakers may be eligible.)
History of active primary immunodeficiency;
Any active neurologic and/or psychiatric disease, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities
History of hemolytic anemia or thalassemia
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others)
Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >= 1.2 mg/dl
Prior history of chronic prostatitis or urethral stricture
Patients with history of erosive esophagitis should be excluded from the study
Known history of cardiomyopathy
History of pituitary or adrenal dysfunction
Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1) individuals with a history of other malignancies are eligible as long as there is no evidence of metastases and life expectancy deemed > 2 years
History of prior >= G 3 hypersensitivity (HSR) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent
No history of sustained ventricular tachycardia (lasting longer than 30 sec) or cardiac arrest
Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
Patients must be questioned for a past medical history of gout; patients must not have a history of gout which can be exacerbated by perifosine
Patients with history of proteinuria grade >= 2
History of congestive heart failure or systolic dysfunction (LVEF <50%)
History of active primary immunodeficiency
Documented history of vesicoureteral reflux
History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
History of glucose-6-phosphate dehydrogenase deficiency
History of seizures, movement disorders or cerebrovascular accident within the past 5 years
Known myopathy or history of rhabdomyolysis
Any history of ventricular arrhythmia
History of seizures, movement disorders or cerebrovascular accident within the past 3 years prior to cycle 1 day 1
Patients with any malignancy who will receive HDMTX given as a 5 g/m^2 infusion over 24 hours and a history of >= 1 of the following:\r\n* Documented decreased renal function, as defined as creatinine greater than 1.5 x baseline or glomerular filtration rate (GFR) < 65 ml/min/1.73m^2\r\n* History of prior nephrotoxicity with HDMTX as evidence by increased creatinine to 1.5 x baseline or need for dialysis or carboxypeptidase\r\n* History of grade 3 adverse event (AE) related to HDMTX (mucositis, myelosuppression, nephrotoxicity, hepatotoxicity) based on the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\r\n* Provider concern patient is at risk for MTX toxicity, such as a prior history of treatment with nephrotoxic chemotherapy, history of HDMTX-related neurotoxicity, or antimicrobial/antifungal therapy
Subjects with a history of Grade 4 astrocytoma.
Subjects with a history of calcium oxalate nephrolithiasis are excluded
History of allogeneic HSCT or prior autologous HSCT
History of pituitary or adrenal dysfunction
History of seizures (taking/not taking anticonvulsants), arteriovenous malformation in the brain, head trauma with loss of consciousness
History of pituitary or adrenal dysfunction
History of RPLS
Known history of Wilson's disease or other copper-related disorders
History of venous thrombosis currently requiring anti-coagulation therapy
Prior history of bowel perforation
Recent history of myocardial infarct (less than 3 months) or history of active angina or arrhythmia
history of arteriovenous malformations of the brain,
history of brain infection (i.e., abscess, meningitis, or encephalitis),
Subject with a history of exposure to enzalutamide.
History of radiation to the chest wall or breast being studied
Inclusion Criteria:\n\n          1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic\n             complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors\n             are excluded.\n\n          2. Pancreatic cancer surgical staging: T 1-3, N0-1, M0.\n\n          3. Subject should be able to start treatment no later than 12 weeks postsurgery.\n\n          4. ?18 years of age at the time of signing the informed consent form (ICF).\n\n          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\n          6. Acceptable hematology parameters:\n\n               -  Absolute neutrophil count ?1500 cell/mm3\n\n               -  Platelet count ?100,000/mm3\n\n               -  Hemoglobin (Hgb) ?9 g/dL\n\n          7. Acceptable blood chemistry levels:\n\n               -  Aspartate aminotransferase (AST)/ Serum glutamic oxaloacetic transaminase (SGOT)\n                  and Alanine transaminase (ALT)/ Serum glutamic -pyruvic transaminase (SGPT) ?2.5\n                  × upper limit of normal range (ULN)\n\n               -  Total bilirubin ? Upper Limit of Normal (ULN) (subjects with Gilbert's syndrome\n                  can have bilirubin of up to 1.5 x ULN)\n\n               -  Alkaline phosphatase ? 2.5 x ULN\n\n               -  Serum creatinine within upper limits of normal or calculated clearance ?50\n                  mL/min/1.73 m2. If using creatinine clearance, actual body weight should be used\n                  for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For\n                  subjects with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used\n                  instead\n\n          8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization\n\n          9. Acceptable coagulation studies as demonstrated by Prothrombin Time (PT) and Partial\n             Thromboplastin Time (PTT) within normal limits (±15%)\n\n        Exclusion Criteria:\n\n        A subject will not be eligible for inclusion in this study if any of the following criteria\n        apply:\n\n          1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma\n\n          2. Presence of or history of metastatic pancreatic adenocarcinoma\n\n          3. Any other malignancy within 5 years prior to randomization, with the exception of\n             adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin\n             cancer (all treatment of which should have been completed 6 months prior to\n             randomization)\n\n          4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic\n             therapy, defined as ongoing signs/symptoms related to the infection without\n             improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment\n\n          5. Known infection with hepatitis B or C, or history of human immunodeficiency virus\n             (HIV) infection, or subject receiving immunosuppressive or myelosuppressive\n             medications that would in the opinion of the investigator, increase the risk of\n             serious neutropenic complications\n\n          6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of\n             their excipients\n\n          7. Serious medical risk factors involving any of the major organ systems, or serious\n             psychiatric disorders, which could compromise the subject's safety or the study data\n             integrity. These include, but are not limited to:\n\n               1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)\n\n               2. History of interstitial lung disease, slowly progressive dyspnea and unproductive\n                  cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary\n                  hypersensitivity pneumonitis or multiple allergies\n\n               3. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial\n                  infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass\n                  graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled\n                  hypertension, clinically significant cardiac dysrhythmia or ECG abnormality,\n                  cerebrovascular accident, transient ischemic attack, or seizure disorder
History of pituitary or adrenal dysfunction
History of tuberculosis or positive purified protein derivative (PPD) test
History of ? Grade 2 pancreatitis
Having at least a 10-pack year history of cigarette smoking
History of suicide attempt or preparation for attempt within the past 10 years
History of bipolar disorder
History of eating disorder such as anorexia or bulimia
History of leptomeningeal disease
History of hepatic encephalopathy
Prior history of hypertensive crisis or hypertensive encephalopathy
Has a history of acute or chronic pancreatitis
Patients have prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
History of pituitary or adrenal dysfunction
Patients who have radiographic evidence of esophageal varices or history of variceal hemorrhage
PART B: History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
PART B: Any history of venous or arterial thrombo-embolism, or previous revascularization procedure
Patients with oropharynx carcinoma with a smoking history of ? 10 pack-year or equivalent 10 year history of tobacco product use and no recent history (within last 5 years) of tobacco use
Smoking history < 10 pack years or equivalent 10 year history of tobacco product use
Any significant tobacco history within the past five years
History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren’s disease
History of leptomeningeal metastases
History of venous thrombosis currently requiring anti-coagulation therapy
History of prior immunotherapy within the last 3 years
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
Patients with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy; patients with a history of contralateral DCIS are not eligible
Diverticulitis (either active or history of) within the past 2 years; note that diverticulosis is permitted
History of asthma
Previous or current history of a myeloproliferative disease
Any history of allergies to grapes or grape seed
History of sarcoidosis
History of hypercalcemia
History of pituitary dysfunction
History of adrenal dysfunction
History of pituitary or adrenal dysfunction
History of progressive multifocal leukoencephalopathy (PML)
History of arterial/myocardial disease
Seizures or history of seizures
History and/or current evidence of clinically relevant ectopic mineralization/calcification
History of angioedema
Prior history of hypertensive crisis or hypertensive encephalopathy
History of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy.
Active smoking within the past 20 years with a cumulative pack year history of > 20 pack years or active smoking (defined as >= 1 cigarette per day) within the last 5 years
History of unstable angina within 1 year prior to study entry
History of acute pancreatitis within 1 year prior to study entry or past medical history of chronic pancreatitis
Prior history of non-arterial ischemic optic retinopathy
History of significant hypotensive episode requiring hospitalization
Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
History of Wilson's disease or other copper-metabolism disorder
History of primary immunodeficiency
Have a history of vitamin B12 deficiency
A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Patient must not have a history of gastric resection (MTD expansion cohort only)
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
Patients with elevated troponin T and/or CK levels (> 1.5 x ULN for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease.
For patients with history of anthracycline exposure or coronary artery disease co-management by cardiology to optimize cardioprotective medications will be required prior to Tosedostat initiation.
History of Barrett's esophagus, esophageal webbing, stricture, or fistula
Patients with history of active seizures are not eligible
History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma controlled with inhaled bronchodilators are eligible)
Prior history of hypertensive crisis or hypertensive encephalopathy
Individuals with a history of asparaginase-associated pancreatitis
History of symptomatic genitourinary stones within the past year
History of grade 3 (Gr. 3) or greater retinopathy or keratitis
Prior history of hypertensive crisis or hypertensive encephalopathy
A history of neurological complications due to poliovirus infection
Genotype: APC mutation (with or without family history) required
Patients with a prior history of documented pancreatitis
History of any disease that could lead to impaired absorption of drugs
History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs
A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
Patients must be ineligible to receive IL-2 based on evidence that may include ischemic heart disease, or arrhythmias, or poor ventricular ejection fraction (< 50%), or respiratory compromise (forced expiratory volume in one second [FEV1] < 60%), or prolonged smoking history, or clinically significant patient history which in the judgment of the investigator would compromise the patient’s ability to tolerate aldesleukin
History or presence of sustained ventricular tachyarrhythmia; (patients with a history of atrial arrhythmia are eligible but should be discussed with Novartis prior to enrollment)
A history of AEs with prior interleukin (IL)-2 or Interferon will not preclude subjects from entering the current study
History of any major disease that might interfere with safe protocol participation
Any prior history of hypertensive crisis or hypertensive encephalopathy
History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
Splenomegaly or history of proliferative hematologic disease
History of hemoptysis
Patients with previous history or current presence of neurological disorders (with the exception of myasthenia gravis), including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes.
Patients with a prior history of a splenectomy and/or sickle cell trait/disease
Patient has a history of listeriosis or prior ADXS11-001 therapy
History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are eligible but should be discussed with the study principal investigator [PI] prior to enrollment)
Prior history of hypertensive crisis or hypertensive encephalopathy
History of intolerance or resistance to lenalidomide
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of primary immunodeficiency
Known history of previous clinical diagnosis of active tuberculosis (this does not include a history of being purified protein derivative [PPD] positive)
History of lupus or scleroderma
h. History of psychotropic drug abuse and inability to quit
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of seizures.
Has a history of ocular melanoma
History of any other active malignancies
No history of distant metastases.
History of primary immunodeficiency
Any prior history of hypertensive crisis or hypertensive encephalopathy
Patients with > 10 pack years of smoking history and/or currently a smoker at the time of treatment
History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL
History of sensitivity to mannitol
Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
History of life threatening or recurrent thrombosis/embolism; subjects may participate if they are adequately anticoagulated during the treatment
Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes
History of immunization with gp100(g209-2M)
History of 15 to 75 PRBC transfusions
History of HIV positivity by (ELISA or Western blot)
History of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment
History of cumulative doxorubicin or liposomal doxorubicin dose > 430 mg/m^2
History of heart disease
History of renal failure requiring dialysis.
History of heart disease.
History of gastrointestinal disease with diarrhea as the major symptom.
History of renal failure requiring dialysis.
History of hypertensive or diabetic retinopathy
History of/or current evidence of hemoptysis (bright red blood of ½ teaspoon or more)
Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose)
Pre-existing severe psychiatric condition or a history of a psychiatric disorder requiring hospitalization or a history of suicidal ideation or attempt
Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
History of impaired adrenal gland function
Patient has a history of autoimmune disorder or immune deficiency disorder
History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
History of major immunologic reaction to any IgG containing agent.
History of pre-existing post-traumatic stress disorder (PTSD)
Known history of positive serum human ADA to trastuzumab.
The donor has existence or recent history of persistent pulmonary infiltrates, recent pneumonia, recent bronchitis, recurrent lung infections, or history or evidence of any lung disease including asthma, or current symptoms of upper respiratory tract infection
Patients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy.
History of splenectomy
Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw
For Post-allo Part B:History of veno-occlusive disease requiring defibrotide
For Post-allo Part B: History of Grade 2 or higher hepatic GVHD
History of Grade ?3 infusion-associated adverse events (AEs) or hypersensitivities to NEOD001 or any of its excipients
History of intolerance to irinotecan at dose-intensity of 125 mg/m^2/2 weeks or lower
History of intolerance to 5-FU at dose-intensity of 1800 mg/m^2/2 weeks or lower
Active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints
History of prior therapy with belinostat or AZD1775
History of other malignancies, except:
History of known congenital hypercoagulable condition
History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
A history of uveitis and/or scleritis
Medical history of orthostatic hypotension.
History of uveitis
History of prior crizotinib use
History of acute or chronic pancreatitis
A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Evidence or history of congenital or acquired hypocoagulability disorders
History of pancreatitis of any grade
History of pancreatitis
History of cranial nerve palsy.
History of corneal disease
History of any disease that could lead to impaired absorption of drugs
History of coronary revascularization or ischemic symptoms
History of current or prior medical problems that the investigator feels will prevent administration of therapy or assessment of response due to excess toxicity
A history of resected pancreatic adenocarcinoma
History of coronary revascularization or ischemic symptoms
Prior history of hypertensive crisis or hypertensive encephalopathy
History of noninfectious pneumonitis
Patients with history of prior HSV encephalitis or encephalitis due to other etiologies
Subject has documented history of allergic response to titanium or silicone
Have a history of a primary adenocarcinoma of the colon and / or rectum
History of exposure to pseudomonas exotoxin containing molecule
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to DSM- IV).
Personal or family history of established Brugada syndrome; if pre-enrollment electrocardiogram (ECG) demonstrates abnormal findings (ST elevation in precordial leads), cardiology consultation should be obtained to rule out presence of this inherited syndrome; patients with family history of unexplained sudden death before the age 45 years; personal history of unexplained syncope or history of unexplained ventricular tachycardia or fibrillation should have a cardiology evaluation to rule out the diagnosis of Brugada syndrome
History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
History of depression or active treatment for depression
History of hypothyroidism or hyperthyroidism
History of significant neurologic or psychiatric disorders, including dementia or seizures that would impede consent, treatment, or follow up
History of suspected history, or presence of heparin induced toxicity (w/ or w/o thrombosis)
Patients with a history of thrombotic or hemorrhagic disorders
Active corneal erosions or history of abnormal corneal sensitivity test
History of orthostatic hypotension
Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
Patients with leptomeningeal disease (LMD) or with a history of LMD will be excluded
History of coronary revascularization or ischemic symptoms
History of prior systemic BCG infection
History of immunosuppression, or conditions associated with congenital or acquired immune deficiency
Patients with no smoking history
History of transformation of indolent disease to DLBCL
Known history of hepatitis C and recovery status has not been determined at time of screening
History of myocardial infarction (MI) documented by elevated cardiac enzymes with persistent regional wall motion abnormality on assessment of left ventricular (LV) function (patients with history of MI must have an echocardiogram (echo) instead of/in addition to a MUGA to evaluate LV wall motion)
History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are eligible but should be discussed with the Novartis prior to enrollment)
History of kidney, ureteral, or bladder stones within the last 5 years
History of or current immunodeficiency disease (e.g. splenectomy or splenic irradiation)
Prior history of a pathologic fracture
History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
History of ventricular tachyarrhythmia within the past 5 years
History of acute pancreatitis within 1 year of study entry
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others).
Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders.
History of progressive multifocal leukoencephalopathy (PML).
History of glaucoma
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the Pharmacodynamic (PD) or efficacy assays
Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
History of sensitivity to any component of SD-101
Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
Prior history of a pathologic fracture
History or suspicion of a congenital or acquired coagulation disorder.
History of other malignancies, except
History of transfusions < 10 RBC units and must not be RBC transfusion dependent
History of adrenal insufficiency
History of or known carcinomatous meningitis
History or presence of sustained ventricular tachyarrhythmia. (Patients with a history of atrial arrhythmia are eligible but should be discussed with the study chair prior to enrollment).
Prior history of hypertensive crisis or hypertensive encephalopathy
History of asthma
Any history of leptomeningeal disease
Patients with carcinomatosis meningitis or a history of ocular/uveal melanoma are excluded.
Participants with known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
History of prior seizures
Known history of mineralocorticoid excess or deficiency (not applicable to patients who have already been treated with abiraterone acetate in first line before inclusion).
History of second primary cancer within the past 5 years, with the exception of:
History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
History of thrombosis due to a known inherited hypercoagulable state
Have a history of tuberculosis and/or received BCG percutaneous vaccination
Patients with a history of proven myocarditis, pericarditis, or endocarditis
History of seizures, movement disorders or cerebrovascular accident within the past 3 years prior to cycle 1 day 1
History of leptomeningeal disease.
History of coronary revascularization or ischemic symptoms
Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, online adaptive SBRT
History of Wilson's disease or other copper-related metabolic disorder
History of non-healing wounds or ulcers.
History of previous therapeutic HPV vaccination;
Patients with known history of Trisomy 21 (Down Syndrome), history of congenital immunodeficiency or inherited marrow failure disorder.
Prior history of hypertensive crisis or hypertensive encephalopathy
Prior history of HNC
History of progressive multifocal leukoencephalopathy (PML)
Prior history of a pathologic fracture
History or signs of active coronary artery disease with or without angina pectoris.
Inadequately controlled hypertension or history of hypertensive crisis or encephalopathy.
Prior history of myositis or rhabdomyolysis.
Recent history of acute pancreatitis.
History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.
History of a prior symptomatic stroke, dementia, or other significant central neurologic condition (i.e. multiple sclerosis)
A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
History of additional risk factors for Torsade de Pointes
Prior history of a pathologic fracture
The subject has a history of delayed healing/open wounds or diabetic ulcers.
Known history of resistance to thalidomide
Previous history of exposure to an anthracycline compound.
History of treatment with an asparaginase agent
Presence or history of hemoptysis (>1/2 teaspoon of red blood) 2 weeks prior to the first dose of GSK3052230
History of pituitary or adrenal dysfunction
Prior history of cardiomyopathy.
PART I: History of iron overload or hemochromatosis
PART I: Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
PART II: History of iron overload or hemochromatosis
PART II: Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
Prior history of psoriasis
History of chronic corticosteroid use
History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab treatment
Known history of sustained (> 30 second) ventricular tachycardia or cardiac syncope. Known history of recurrent non-sustained ventricular tachycardia (> 3 beats) despite anti-arrhythmic therapy
History or presence of ventricular tachyarrhythmia
A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Active joint inflammation or history of inflammatory arthritis or other immune disorder involving the joints
Treated and followed for at least the past 2 years in a specialized center that maintained detailed medical records, including transfusion history.
The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
History of pituitary dysfunction
Known history of pituitary or adrenal dysfunction
History of acute coronary syndromes.
History of hypertensive crisis or hypertensive encephalopathy
Subjects with a history of RSV or MPV
Subjects with a history of documented Pseudomonas aeruginosa pneumonia confirmed radiographically and by culture from BAL.
Recent (3 months) history of acute pancreatitis.
History of transformation of indolent disease to DLBCL
Subjects with a history of NF-1 related cerebral vascular anomaly (such as Moyamoya).
History of heparin-induced thrombocytopenia.
Prior history of chronic prostatitis
Prior history of urethral stricture
Patients with history or evidence of lactic acidosis or metabolic acidosis will be excluded
History of coronary revascularization or ischemic symptoms
History of coronary revascularization or ischemic symptoms
A history of metabolic acidosis, including ketoacidosis or increased risk of lactic acidosis
Patients with a history of renal disease
Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
History of pituitary or adrenal dysfunction
History of lobectomy involving > 50% of lobe
Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML
History of cirrhosis
History of active current coronary artery disease or unstable angina
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
Hyperuricemia, history of gout, high uric acid, and/or kidney disease
Hyperuricemia, history of gout, high uric acid, and/or kidney disease
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
Subjects with recent history of thyroiditis
Patients with a history of D835 mutations
Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
History or presence of ventricular tachyarrhythmia
cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
History of significant neurological or psychiatric disorders
History or current symptoms of congestive heart failure (shortness of breath, ankle swelling)
History or current evidence of hyperthyroidism that would increase metabolism of Itraconazole
History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.
History of porphyria.
History of known Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency.
History of epilepsy or seizures in the past 20 years.
History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
History of medical or psychiatric disease, active substance abuse or social circumstances which in the view of the principal investigator, would preclude safe treatment
Patients with history of autoimmune disease (excluding thyroiditis on chronic thyroid replacement therapy) or active auto-immune disease, due to a risk of exacerbation of autoimmunity with r-hIL7; patients with a history of B cell malignancy due to a risk for growth with rhIL7 therapy
History of:
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Patients with a history of peptic ulcer disease
Patients with recent history of kidney stones.
Patients with recent history of pancreatitis
History of Wilson's disease or other copper-related metabolic disorder
Any history of metastatic TCC; subjects with suspected malignant lymphadenopathy in the abdomen or pelvis are not allowed
History of sensitivity to mannitol
Patients with history of confirmed progressive multifocal leukoencephalopathy
History of main or lobar portal vein thrombosis
History of major implant(s) or device(s), including but not limited to: \r\n* Prosthetic heart valve(s) \r\n* Artificial joints and prosthetics placed =< 12 months prior to treatment initiation \r\n* Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
History of primary immunodeficiency
History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
History or current evidence of:\r\n* Tissue calcification including, but not limited to, the soft tissue, kidneys, intestines, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification\r\n* Endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc
Known homozygous for UGT1A1*28 mutation from prior testing or family history
History of coronary revascularization or ischemic symptoms
History of coronary revascularization or ischemic symptoms
History of life threatening or recurrent thrombosis/embolism; patients may participate if they are on anticoagulation during the treatment
History of leptomeningeal metastases
Patients with a known history of proven myocarditis, pericarditis, and/ or endocarditis
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug
Prior history of rhabdomyolysis
Prior history of lactic acidosis
Any history of second or third degree heart block;
Current or history of anorexia or bulimia in the past 5 years
History of Parkinson’s disease, multiple sclerosis or fibromyalgia
History of steroid psychosis
History of or active glaucoma
No history of seizures
Not currently on renal dialysis or has a history of significant renal impairment
Patients with a history of prior (ipsilateral [ipsi]- and/or contralateral) invasive BC
Prior history of neurologic or psychiatric disease believed to impact cognitive function
Patient is a current or ex-smoker with a smoking history of >= 10 pack years
DCIS prior to index lesion or history of progressive/recurrent DCIS after treatment
Participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, antithrombin [AT]-III deficiency, etc.), platelet disorder or bleeding disorder
Self-reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
History or diagnosis of a disease affecting hemostasis
A history of orchiectomy
History of unexplained syncope or family history of idiopathic sudden death
History of blood clot;
History of cerebellar toxicity or cerebellar neurological findings on exam
History of immune-mediated pneumonitis
History of leptomeningeal disease
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis
History of endometrial neoplasia
History of thromboembolic disease (history of varicose veins and superficial phlebitis is allowed)
History of primary immunodeficiency
History of pituitary or adrenal dysfunction
Prior history of hypertensive crisis or hypertensive encephalopathy within the previous 3 months of first study treatment
Patient must not have a history of Raynaud’s disease
No history of cognitive disorder
No history of mood disorder
History of intolerance of oxycodone.
History of bipolar disorder diagnosis
History of eating disorder (ever uncontrolled or any within the last two years)
History of previous experience with smoking or marijuana
History of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
History of uncontrolled depression or other psychiatric comorbidity with psychosis
History of interstitial cystitis
History of nasal or sinus anomalies or dysfunction e.g. allergic or infectious rhinitis
Documented history of medication abuse/misuse (e.g. unsanctioned dose escalation, broken opioid agreement etc.)
Patients with a confirmed history of calcium oxalate nephrolithiasis are excluded; patients with a significant history of malabsorption (e.g. celiac sprue, short bowel syndrome, inflammatory bowel disease [IBD] or other, as determined by the treating physician) are excluded; patients will not be eligible if actively receiving treatment for vitamin D deficiency and have had recent (3 month) history of vitamin D supplementation (> 1000 IU)
Is known or suspected to have a (family) history of malignant hyperthermia
Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
No history of celiac disease or non-celiac gluten sensitivity
Subjects with a history of anxiety-induced (“anticipatory”) nausea and vomiting
No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
Male patients with a history of untreated hypogonadism
PATIENTS: History of myasthenia gravis or acute narrow angle glaucoma
PATIENTS: History of Parkinson’s disease or Alzheimer’s dementia
Patients who have a history of duodenal ulcer or duodenal fibrosis
Subjects with a current or past history of schizophrenia will also be excluded
History of neurologic illness such as stroke, multiple sclerosis, multi-infarct dementia, or Parkinson’s disease or history of dementia or chronic fatigue syndrome
Recent history of falls or balance problems
As per self-report and/or medical record history of diagnosed neurological illness including seizure disorder, a dementing condition, or other neurological illness (multiple sclerosis, history of cerebrovascular accident, etc.)
Participants with untreated depression or anxiety as assessed by self-report and review of medical history
Participants with a history of treated or untreated schizophrenia or bipolar disorder as assessed by self-report and review of medical history
As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
History of pre-existing neuropathic pain conditions
Known medical history of significant psychiatric or cognitive impairment
History of recurrent or second primary H&N, central nervous system, or thoracic cancer at time of modified barium swallow (MBS) study
A history of gastric or duodenal ulcers or hyperacidity syndromes
Smoking history of 30 pack-years or greater
Documented history of Alzheimer’s disease, dementia, or other neurologic deficit that could impact decision-making
History of patient reported PONV, chemotherapy-induced nausea and vomiting (CINV) or motion sickness
History of cerebral vascular accident (CVA) or other central nervous system disorder resulting in residual weakness or paresis of extremity contralateral to the site of disease
Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
Active hemoptysis or history of clinically relevant hemoptysis as determined by the treating physician; patients who had history of transient minor hemoptysis after bronchoscopic biopsy are eligible unless deemed otherwise by the treating physician
Blind or having a history of eye disease including, but not limited to, macular degeneration, or other diagnosed retinal problems
History of serious mood disorder or attempted suicide as determined by patient’s history and physical and by using the Depression Screening; subjects with a score of greater than 10 or those answering #5 with scores greater than a \0\ will be deemed ineligible to be enrolled on study
History of angioedema
Platelets < 150 mg/dL or history of thrombocytopenia
Lower extremity neuropathy per patient report attributable to oxaliplatin, docetaxel or paclitaxel (neurotoxic chemotherapeutic agent) as determined by patient history of neurotoxic agent administration and no history of other attributable causes such as diabetic neuropathy
Patients with a history of enfuvirtide resistance
History of marked anxiety disorder, or history of substance abuse
Unable to provide medical history
Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia; (defined per medical history)
Co-morbid disease or incurrent illness such as:\r\n* History of head trauma \r\n* History of nasal surgery other than biopsy (before cancer was diagnosed)\r\n* History of sinus surgery other than biopsy (before cancer was diagnosed)\r\n* Chronic rhinosinusitis with or without polyp \r\n* Pregnancy \r\n* Cognitive dysfunction \r\n* History of brain surgery \r\n* Psychiatric or neurologic diseases interfering with sense of smell \r\n* Congenital disorders of olfactory dysfunction \r\n* Olfactory loss prior to onset of nasopharyngeal carcinoma
Known history of a neurological and/or psychological disorder that in the physician’s opinion may interfere with the patient’s ability to cooperate with study procedures
History of bipolar affective disorder or psychosis
History of chronic pain and/or daily opioid use
History of intolerance to negative pressure wound therapy
Medical history of concussions
Patients with a documented history of invasive fungal infection (IFI) within the previous 30 days are not eligible
Personal history of migraine, cluster or tension headaches
Prior history of hypertensive crisis or hypertensive encephalopathy
Patients must not have any contraindicated concurrent illnesses listed on the duloxetine package insert including:\r\n* Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder\r\n* History of alcohol or other substance abuse or dependence within 365 days prior to registration\r\n* Chronic liver disease\r\n* End-stage renal disease\r\n* Uncontrolled narrow-angle glaucoma\r\n* Clinically significant coagulation disorder
Have a history of dementia or major neurological illness
Known re-expandable lung:\r\n* History of recurrent transudative (by Light’s criteria) pleural effusions of known etiology, AND\r\n* Has undergone multiple prior thoracenteses, without history of significant chest discomfort, AND\r\n* Strong clinical suspicion that the current effusion is uncomplicated and due to the known underlying etiology
Strong, self-reported history of postoperative nausea and vomiting
Participants will have no previous history of clinical trial research participation
No history of hemorrhagic stroke
Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction.
Subjects who have unknown transfusion history for at least the 12 weeks prior to screening
Personal history of an eating disorder
History of multiple CDI
History of gastrointestinal or genitourinary obstruction or porphyria
Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
History of a chronic medical condition that has the potential to significantly impact upper extremity function (e.g. stroke, Parkinson’s disease, multiple sclerosis)
Have no clinical history of disease (e.g., multiple sclerosis, fibromyalgia) that could account for their fatigue presentation
History of heparin induced thrombocytopenia
Patients may or may not have a history of lymphedema or have been treated for lymphedema
History of seizures
At least a 30 pack-year smoking history
No history of untreated narrow angle glaucoma within 6 weeks prior to registration
Patients with prior history of HSCT
History of diagnosis of neurogenic bladder.
History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
Subject is pregnant, planning to become pregnant, or is lactating. 4. Subject has a history of empyema. 5. Subject has a history of chylothorax. 6. Subject has an uncorrected coagulopathy. 7. Subject has a hypersensitivity to new or existing pleural catheter or it's components.
Has history of calcium oxalate stones
Has history of iron overload
No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
History of or current hepatic encephalopathy or clinically meaningful ascites.
=< 10 pack-years smoking history or =< 30 pack-years smoking history WITH >= 5 years abstinence from smoking
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Women with no history of cancer
History of Sjogren’s, lupus or scleroderma
History of myasthenia gravis or acute narrow angle glaucoma
History of Parkinson’s disease or dementia
Patient must not have history of prior cranial radiotherapy
Prior history of acupressure use
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
No history of bronchial asthma or related bronchospastic conditions
History of Guillain-Barre within 6 weeks of previous influenza vaccination
History of neutralizing antibody activity to recombinant human erythropoietin (rHuEPO) or darbepoetin alfa.
History of pure red cell aplasia
No history of Paget’s disease
No history of epilepsy/seizures
History of phenylketonuria (PKU)
History of polycythemia
Patients with a history of severely impaired autonomic control of blood pressure
Patients with a history of existing hypercalcemia, hypocalcemia, hypermagnesemia or hypomagnesemia that is not corrected despite supplementation
Known urea cycle disorders based on history
Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks and incompletely healed surgical incision before randomization
Evidence of empyema or history of empyema of the affected hemithorax
History of seizures
Patients with a history of or current bowel obstruction
Patients will be excluded from the trial if they have had a history of allergies or intolerance to fructooligosaccharides or the components of FOS including fructose and glucose
History of Post-traumatic Stress Disorder
History of multiple cancers
Patients have a known history of seasonal affective disorder or substance abuse
Medical history of atrial fibrillation or arrhythmia
Presence or recent history of any systemic disorder or conditions, such as:
Prior history of hearing impairment
History of seizures
History of primary (congenital) lymphedema
Patients who have a history of breast tissue expander or implant placement
Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Known history of hemolysis and/or methemoglobinemia
Subjects with history of presumed or proven invasive fungal infection within 30 days of randomization
History of demyelinating disorder
History of bone fractures
History of gastrointestinal or genitourinary obstruction or porphyria
Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture
Patients with a prior history of colonic surgeries
No history of CRC
Women who report no history of Pap screening within the last four years
Women who report no history of co-testing (Pap and HPV) within the last five years
Must be willing to complete demographic, family history, personal health and medication history, and informed consent
Personal history of pancreatic adenocarcinoma
PRELIMINARY TEST: No history of hysterectomy
Individuals that have a personal or family history of CRC (previous adenomatous polyp), and/or, have a signs and symptoms colonoscopy order from their primary care physician
Patients determined to be at risk for esophageal cancer:\r\n* Subjects with a history of Barrett’s esophagus\r\n* Subjects with a history of low or high grade dysplasia\r\n* Subjects with a history of gastroesophageal reflux disease (GERD)\r\n* Subjects with a history of esophagitis\r\n* Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.
Patients have no known coagulopathy and no known history of esophageal varices
Patients have known coagulopathies or history of esophageal varices
Personal or family history (1st degree relative) of colon cancer
History of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
Prior history of documented venous thromboembolic event within the last 5 years (excluding central line associated events whereby patients completed anticoagulation)
History of receiving 2016-2017 influenza vaccine
History of proven influenza disease after September 1, 2016
FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: History of receiving current year seasonal influenza vaccine influenza vaccine
FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: History of proven influenza disease after September 1, 2017
Survey response indicated no prior history of HPV vaccination
History of receiving 2017-2018 influenza vaccine
History of proven influenza disease after September 1, 2017
Current diagnosis or history of cardiac pre-excitation syndromes (e.g. Wolff-Parkinson-White)
Current or ex-smoker with at least 10 pack-year history
History of known thyroid disease
History of known sarcoid disease
History of known abnormalities in calcium metabolism
History of known renal dysfunction
History of known nephrolithiasis (kidney stones)
Have at least a 30 pack-year history of smoking
History of chronic myopathy
History of pancreatic adenocarcinoma (at any time)
History of chronic sinusitis or recent nasal polyps
History or presence of sustained ventricular tachycardia
History of chronic myopathy
History of heparin induced thrombocytopenia
WHITE, NON-HISPANIC: Without a personal history of melanoma.
H/L: Participants with a personal history of melanoma and/or more personal history of more than one SCC and/or BCC.
A history of adverse reaction to IV thiamine
For patient with known history or predisposition to cardiac abnormalities: in the Investigator's opinion the history/predisposition should not jeopardize patient's safety during the study.
Individuals with a history of any skin cancer, melanocytic lesions, actinic keratoses or actinic damage in the test area are ineligible; history of such conditions at a body site other than the test area is not exclusionary if in the opinion of the study physician it will not pose a risk to the subject
Individuals with a history of natural or artificial sun exposure to the buttocks within 30 days of study participation are not eligible
No history of celiac disease or non-celiac gluten sensitivity
Women with a prior history of cardiovascular disease, defined as a 1 or more positive responses on the Heart Questionnaire
History of disordered eating as indicated by the Eating Disorder Examination Questionnaire (EDEQ)
Have a personal history of melanoma and/or family history of melanoma (see definition under child eligibility criteria below)
Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma and/or
Patients with a history of hypocalcemia
History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart failure, ischemic cardiomyopathy
Patients with a history of pancreatitis
>= 1 year history of smoking, and smoking >= 5 cigarettes per week
Have a prior history of lactic acidosis by self-report
History of panic disorder, psychosis, bipolar disorder, or eating disorders
Eligible participants for focus groups include current or former smokers who are between 55-80 with a 30 pack­-year history
Participants must have a smoking history of 20 pack-years or greater
History of chronic myopathy
History of GI ulcers, chronic GERD, or GI bleeding in the past 5 years
History of claustrophobia
Women with known osteoporosis or history of osteoporotic (fragility) fracture of the spine
Current smokers or subjects with any history of smoking
Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer
Individuals with a history of colon resection or colectomy due to any reason
Individual with history of gastric bypass due to any reason
History of diabetic ketoacidosis
History of renal disease
Healthy on the basis of medical history
Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years
Subjects may be taking calcium supplements or have previous history of hypercalcemia
History of lactic acidosis
History of B12 deficiency
Patients with a documented history of coagulopathy such as hemophilia or von Willebrand’s disease or inherited thrombophilia
Participants who exhibit confusion, disorientation, or have a history of major psychiatric illness which may impair their understanding of the informed consent
History of gastroduodenal ulcers documented =< 1 year
Current or history of hepatic dysfunction
A subject with a history or expectation of noncompliance with medications or treatment protocol
Has a history of anaphylaxis attributed to the azole class of antifungal agents
PHASE I: Individuals at risk for lung cancer based on a smoking history of 20 or more pack/years of cigarette smoking
STUDY I: >= 1 year history of weekly smoking
Generally good health as determined by medical history
Prior history of malignancies, other than MDS (MYELODYSPLASTIC SYNDROMES), unless the subject has been free of the disease for ? 3 years. However, subjects with the following history/concurrent conditions are allowed:
History of primary immunodeficiency
Subjects with a history of primary idiopathic myelofibrosis.
History of primary immunodeficiency
History of leptomeningeal carcinomatosis
No history of uncontrolled seizures after surgery for primary GBM (despite adequate antiepileptic therapy) or with need for concurrent administration of more than 2 antiepileptic drugs.
Have a history of lactic acidosis or risk factors for lactic acidosis
Have a history of alcoholism or high alcohol consumption (average of > 3 standard drinks/day)
History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators
History of 1 or more adenomatous polyps
Current or ex-smoker with at least a 10-year pack history
History of known thyroid disease
History of known sarcoid disease
History of known abnormalities in calcium metabolism
History of known renal dysfunction
History of known nephrolithiasis (kidney stones)
Personal history of polyps
Personal history of CRC
History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone
History of relapse of ALL
Positive history of a medical condition that precludes use of the nicotine patch
History of chronic sinusitis or recent nasal polyps
History of gastroparesis
History of celiac disease
History of difficulty with sigmoidoscopy or abnormal colorectal anatomy
History of food allergies and/or major dietary restrictions
Have a history of gallstones
History of panic disorder, psychosis, bipolar disorder, or eating disorders
Current or history of anal or peri-anal carcinoma
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
History of any neurological disorders or seizures.
History of radical prostatectomy
History of bone fracture after the conclusion of chemotherapy\r\n* History of bone fracture will be based on patient/parent report of fracture occurrence and will be confirmed in review of the medical record whenever feasible
Individuals with history of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis
With history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (> 60 minutes), as per medical records or patient report
History or diagnosis of Paget’s disease
Subject has history of primary immunodeficiency
Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
Unable to provide history
History of anaphylactoid reaction to iodinated contrast material
History of previous administration of GBCA
History of renal disease, hypertension, diabetes, congestive heart failure or emphysema
History of reaction to ICG, iodides, or technetium radiocolloid
No prior history of breast reconstruction, reduction, or augmentation
History of pneumonitis requiring hospitalization or systemic immune suppressive therapy
Subjects with a history of low or high grade dysplasia
Known history of cerebrovascular disease, dementia or prior non-mild traumatic brain injury
History of high grade anal intraepithelial neoplasia (AIN 2 or 3)
History of allergies to iodides
History of hemibody external radiotherapy as assessed by medical record review
Subjects with a history of iodide allergies
Have known history of kidney diseases
History of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions
History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening
History of cardiovascular disease that may adversely affect patient participation at the discretion of the primary investigator
History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis
At the discretion of the operating surgeon, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert’s)
Known history of claustrophobia
In order to identify subjects at risk for the development of NSF, the American College of Radiology (http://acr.org) recommends obtaining a medical history and a glomerular filtration rate (GFR) assessment within six weeks of MR imaging in the following patients: \r\n* Renal disease (including solitary kidney, renal transplant, renal tumor)\r\n* Age > 60\r\n* History of hypertension\r\n* History of diabetes\r\n* History of severe hepatic disease/liver transplant/pending liver transplant
History of primary lymphedema
At the discretion of the physician, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's)
Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
History of chronic asthma
Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations
History or currently taking immunosuppression
Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
or have a history of kidney disease.
The protocol nurse will check with the patient that there is no history of (h/o) kidney disease
History of Meniere’s disease
History of pituitary or adrenal dysfunction
History of seizures
Participants that have a known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
History of median sternotomy
History of or currently active primary or secondary immunodeficiency.
Subjects must not have a history of primary immunodeficiency.
Primary immunodeficiency
History of leptomeningeal metastases
Patients in Canada may not have a history or evidence of latent or active tuberculosis infection.
History of secondary hyperparathyroidism
Personal or family history of porphyrias
History of having undergone any local ablative therapy to liver prior to enrollment on the trial
Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
Has a history of:\r\n* Neuropathy or numbness/tingling suspicious for neuropathy prior to the first dose of chemotherapy for ovarian cancer\r\n* History of prior treatment for other cancers that includes drugs known to cause neuropathy; these drugs include but are not limited to vinca-alkaloids, platinums, taxanes, bortizomib.\r\n* B12 deficiency\r\n* Known peripheral vascular disease\r\n* Chronic daily headache or headache more than 14 days of the month
Prior history of prostatectomy
Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)
Personal or family history of porphyrias
History of bilateral orchidectomy
Personal or family history of porphyrias
A known history of contrast sensitivity
History of symptomatic genitourinary stones within the past year
History of reactive hypoglycemia
Active or history of lactic acidosis, metabolic acidosis, or diabetic ketoacidosis
Patients with a known history of psychiatric issues
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure
Have a history of alcoholism
Patients with a history of coronary artery disease must have had a normal stress test within 180 days of starting IFN gamma
Inclusion criteria (for all subjects)\n\n          -  Male and/or female subjects 18-75 years of age\n\n          -  Females must be of non-childbearing potential . All non-postmenopausal females must\n             have a confirmed negative serum pregnancy\n\n          -  Subjects in good health condition as determined by no clinically significant findings\n             from medical history and physical examination.\n\n          -  Body mass index (BMI) between ?18.0 and ?38.0 kg/m2, with body weight ? 50 kg and no\n             more than 140 kg\n\n          -  Laboratory values must be within normal limits (correction allowed) or considered\n             clinically insignificant\n\n          -  Do not participate in any other clinical trials with a BRAF or other RAF inhibitors\n\n        Additional inclusion criteria for patients with normal hepatic function (Control group):\n\n          -  Absence of clinically significant deviation from normal in medical history, physical\n             examination, vital signs, electrocardiograms and clinical laboratory determinations.\n\n          -  Must match to at least one hepatic impairment subject by age, gender and bodyweight\n\n        Additional inclusion criteria for hepatic impaired subjects:\n\n          -  Confirmed hepatic disease\n\n          -  Stable Child-Pugh status within 28 days prior to dosing.\n\n        Exclusion criteria for all subjects\n\n          -  Participation in any clinical investigation within 4 weeks prior to dosing\n\n          -  Significant acute illness within the two weeks prior to dosing\n\n          -  History of immunodeficiency diseases, including a positive HIV\n\n          -  History of malignancy of any organ system, treated or untreated, within 5 years\n\n          -  Any prior history of keratoacanthoma and/or cutaneous squamous cell carcinoma\n\n          -  A known diagnosis of any of the RASopathies, such as NF-1, Noonan syndrome, or related\n             conditions.\n\n          -  History of drug or alcohol abuse within the 6 months prior to dosing\n\n          -  Smoking: urine cotinine levels below 500 ng/mL on Day -1.\n\n          -  Use of drugs known to affect CYP3A4 and/or CYP2C8 including both (strong or moderate)\n             inhibitors and inducers, within 7 days prior to dosing\n\n          -  Administration of medications that prolong the QT interval within 4 weeks prior to\n             dosing and until EOT.\n\n          -  History or current diagnosis of cardiac disease indicating significant risk of safety\n\n          -  Any surgical or medical condition which might significantly alter the absorption,\n             distribution, metabolism or excretion of drugs.\n\n        Additional exclusion criteria for healthy subjects (control group):\n\n          -  Clinical evidence of liver disease or liver injury\n\n          -  History or presence of renal impairment as indicated by abnormal creatinine or BUN\n             values\n\n          -  A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody\n\n        Additional exclusion criteria for subjects with hepatic impairment:\n\n          -  Alcohol or drug abuse within one month prior to dosing or evidence of such\n\n          -  History of liver transplantation at any time in the past and is on immunosuppressant\n             therapy.\n\n          -  Encephalopathy Grade 3 or worse within 28 days of dosing.\n\n          -  History of surgical portosystemic shunt.\n\n          -  Life expectancy ?3 months\n\n        Other protocol-defined inclusion/exclusion may apply.
History of lactic acidosis as per prior medical records or provided by the patient
Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions
Have a history of peptic ulcer disease within the last 12 months unless adequately treated as assessed by the participant’s primary care physician or medical oncologist
History of head injury or dementia.
History of cognitive impairment.
No history of colon cancer or colon resection
History of colon cancer or colon resection
Current smoker, or former smoker who has less than a 16-year quit history
Have at least a 30-pack year smoking history (average packs per day x years smoking)
A personal history of CRC
History of autoimmune disorders, including rheumatic diseases and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
History of iritis or episcleritis.
Patients with a history of non-compliance to CML treatment and monitoring requirements
History of re-irradiation to a field which includes the carotid arteries
History of unstable angina within 1 year of study entry
History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
Has a history of any major neurological disorders, including stroke, multiple sclerosis, or neurodegenerative disease.
History of carcinomatous meningitis.
History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months
History of glaucoma
Previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum
Suspicion or known history of gastrointestinal obstruction
History of stroke with the past year
History or evidence of giant congenital melanocytic nevi, dysplastic nevis syndrome or xeroderma pigmentosum.
History of heart disease
Known history of positive serum human ADA.
Patient has a history of other malignancies within the last 5 years
History of Richter’s or prolymphocytic transformation