Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents while on study
Patients may not be receiving any other investigational agents while on study
Patients must not be receiving or planning to receive any other investigational agents
Patients may not be receiving any other investigational agents while on study treatment
Patients receiving ongoing treatment with any other investigational agents are not eligible
Patients may not be receiving any other investigational agents
Patients may not be receiving or have received any other investigational agents during/or within 1 month prior
Patients receiving any other investigational agents are ineligible
Patients receiving any other investigational agents are excluded
Subjects who are receiving any other investigational agents
EXCLUSION CRITERIA FOR THIRD-LINE THERAPY: Patients receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patient is receiving any other investigational agents.
Patients who are receiving any other investigational agents
Patients receiving ongoing treatment with any other investigational agents are not eligible
Receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents.
Receiving any other investigational agents
Patients must not be receiving any other investigational agents
Receiving any other investigational agents for their lymphoma
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Receiving any other investigational agents
Patients receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational therapy
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents are excluded
Patients receiving any other investigational agents
Patients may not be receiving any other anti-neoplastic investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other therapeutic investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents, or have received investigational agents within 4 weeks of beginning treatment
Patients may not be receiving (or received prior to enrollment) any other investigational agents for metastatic disease.
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents for treatment of their kidney cancer
Patients who are receiving other investigational agents
Patients who are actively receiving any other investigational agents
Patients who are receiving any other investigational agents
Patient must not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents or other tumor-directed therapy.
Patients who are receiving any other investigational agents
Patients receiving other investigational agents.
Patients who are receiving any other investigational agents.
Patients who are receiving any other investigational agents
Patient is receiving other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents.
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents for the treatment of their breast cancer
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents are ineligible
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other anticancer or investigational agents
Patients must not be receiving any other investigational agents
Patients may not be receiving any other investigational agents within 30 days of registration
Patients must not be receiving any other investigational agents
Patients receiving other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents.
Patients who are receiving any other investigational agents
Subjects who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents.
Patients who are receiving any other investigational agents.
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents =< 28 days prior to study treatment
Patients receiving any other investigational agents within 30 days of receiving zydelig
Patients who are receiving any other investigational agents
Subjects receiving any other investigational agents
Patients receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects who are receiving any other investigational agents
Patients receiving other investigational agents
Patients receiving any other investigational agents
Patients who are receiving any investigational agents
Patients who are receiving any other investigational agents or other tumor-directed therapy
Patients receiving any other investigational agents
Subjects may not be receiving any other investigational agents
Patients who are receiving any other investigational agents within 28 days before start of study treatment
Subjects may not be receiving other investigational agents
Patients may not be receiving any other investigational agents =< 14 days from registration
Patients who are receiving any other investigational agents or have within the last 28 days
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Subjects receiving any other investigational agents
Receiving any other investigational agents within 14 days prior to enrollment
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents are ineligible
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects receiving other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents (with exception of imaging agents)
Patients who are receiving any other investigational agents; however, prior enrollment on a study using investigational agents is acceptable
Patients who are receiving any other investigational agents within the preceding 4 weeks
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients receiving any other investigational agents
Patients receiving any investigational agents
Patients receiving any other investigational agents
Patients receiving any other investigational agents or immunotherapy
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents within the preceding 4 weeks
Subjects receiving any other investigational agents
Patients who are receiving any investigational agents
Patients who are receiving any investigational agents
Patients may not be receiving any other investigational agents
Subjects who are actively receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents.
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks
Subjects who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational therapeutic agents
Subjects may not be receiving any other investigational agents
Patients who are receiving other investigational therapeutic agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Subjects is receiving any other investigational agents for the treatment of prostate cancer
Patients may not be receiving any other investigational agents
Subjects must not be receiving any other investigational agents
Patients receiving any other investigational agents.
Patients may not be receiving any other investigational agents
Patients receiving any other investigational agents
Patients may not be receiving any other investigational agents and/or other therapy for their cancer
Patient must not be receiving any other investigational agents
Patients may not be receiving any other investigational cancer treatment agents at the time of enrollment
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Receiving any other investigational agents =< 28 days prior to registration
Patients receiving any other investigational agents are ineligible
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects who are receiving any other investigational agents
Patients receiving any other investigational agents are ineligible
The subject is receiving any other investigational agents
Patients receiving any other investigational agents
Patients may not be receiving any other investigational agents
TUMOR BIOPSY SEQUENCING: Patients who are receiving any other investigational agents; patients on other trials will be eligible as long as they are no longer receiving study treatment
TREATMENT: Patients who are receiving any other investigational agents; patients on other trials will be eligible as long as they are no longer receiving study treatment
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients must not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents
Patients who are receiving any other biologic, cytotoxic or investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
Subjects may not be receiving any other investigational agents
Patients receiving any other investigational agents
Receiving other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents are ineligible
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any additional investigational agents or radiation therapy
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents for melanoma
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents are not eligible
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
PHASE II: Patients may not be receiving any other investigational agents while on study
Patients must not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients receiving any other investigational agents
May not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents for cancer
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Subject who is receiving any other investigational agents;
Patients who are receiving any other investigational agents
Not receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients must not be receiving any other investigational agents
Subjects receiving any other investigational agents
Receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Receiving any other investigational agents at the time of registration
Patients who are receiving any other investigational agents
Patients must not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects receiving any other investigational agents
Patients may not be receiving any other investigational agents within 2 weeks prior to registration
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patient receiving any other investigational agents
Patients may not be receiving any other investigational cancer-directed agents
Actively receiving any investigational agents
Patients receiving any other investigational agents within 30 days prior to the first dose of trial treatment
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving other investigational agents
Patients who are receiving any other investigational agents
Subjects receiving other investigational agents are not eligible
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
Patients may not be on any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Subjects may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients should not be receiving any other investigational agents
Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents for cancer treatment
Patients may not be receiving any other investigational agents while on study treatment
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents while on study
Patient receiving any other investigational agents
Patient must not be receiving any other investigational agents
Patients who are receiving any investigational agents
Patient must not be receiving any other investigational agents
Patients who are receiving any investigational agents.
Patients may not be receiving any other investigational agents
Patients receiving any other chemotherapy or investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Subjects receiving any other investigational agents
Subjects receiving other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents.
Patients receiving any other investigational agents
Patients receiving other investigational agents
Receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients should not be receiving any other investigational agents
Patients should not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Receiving any other investigational agents
Patients may not be receiving any other investigational agents.
Patients receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents or other medications for the treatment of their malignancy
Patients receiving any other investigational agents
Patients receiving any other investigational agents are ineligible
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents or have received immunotherapy
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
Patients may not be receiving any additional investigational agents or radiation therapy
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents within 28 days before start of study treatment
Patients should not be receiving any other investigational agents
Patients may not be receiving any investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patient must not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents.
Patients receiving any other investigational agents are ineligible
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients planning on receiving other investigational agents while on this study
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents or have received other investigational agents for at least 3 weeks
Patients who are receiving any other investigational agents
Patients may not be receiving any other investigational agents within 7 days of registration
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients who are receiving any other investigational agents
Subjects may not be receiving any investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents are ineligible
Patient must not be receiving any other investigational agents
Patient must not be actively receiving any other investigational agents
Receiving any other investigational agents =< 6 months prior to registration
Receiving any other investigational agents =< 6 months prior to Registration
Receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Receiving any other investigational agents
Receiving any other investigational, anticoagulation, and/or chemotherapy agents
Participant is receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents are ineligible
Patients may not be receiving any other investigational agents
Receiving any other investigational agents
Patient may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Patients may not be receiving any other investigational agents
Women who are receiving any other investigational agents
Receiving any investigational agents
Subjects may not be receiving any investigational agents
Patients who are receiving any other investigational agents
Patients receiving any other investigational agents within 4 weeks of starting the study
Patients may not be receiving any other investigational agents
Patients who are receiving any other investigational agents
Patients receiving
Patients who are receiving any other investigational agents
Patients with a history of, or current grade 4 depression are not eligible
Current evidence of any of the following:\r\n* Known gastrointestinal disorder affecting absorption of oral medications\r\n* Active uncontrolled infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) \r\n* Uncontrolled hypertension\r\n* Any current condition that in the opinion of the investigator, would preclude participation in this study
Inclusion Criteria:\n\n        • Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or\n        syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities\n        which could increase the risk of toxicity and/or early death of intensive chemotherapy in\n        the opinion of the investigator and are not contra-indicated for non-intensive\n        chemotherapy.\n\n        or ? 75 years with or without any comorbidity at the time of the informed consent\n        signature;\n\n        • Newly diagnosed, untreated de novo or secondary AML according to WHO classification;\n\n        Exclusion Criteria:\n\n          -  Prior or current treatment with chemotherapy for any myeloid disorder (excluding\n             hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of\n             randomization;\n\n          -  Prior treatment with decitabine, azacitidine, or cytarabine;\n\n          -  Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma\n             of the skin, or carcinoma \ in situ \ of the cervix or breast;\n\n          -  Chronic myelogenous or acute promyelocytic leukaemia;\n\n          -  Known CNS involvement;\n\n          -  Patient eligible to bone marrow or stem cell transplant;\n\n          -  WBC ? 30.000/mm3;\n\n          -  Impaired renal function with Creatinine clearance < 30 mL/min/1.73m² according to the\n             MDRD formula;\n\n          -  Serum bilirubin ? 2.5 x ULN and/or AST and/or ALT ? 2.5 x ULN (upper limit of normal\n             value);\n\n          -  Calcemia ? 2.65 mmol/L (106 mg/L) at screening assessment (corrected with\n             albuminemia);\n\n          -  History of diseases known to be associated with calcium disorders: ongoing\n             hyperparathyroidism, sarcoidosis….;\n\n          -  Presence or history of symptomatic kidney stones in the last 5 years;\n\n          -  Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen\n             phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or\n             to the excipient of inecalcitol tablets (lactose);\n\n          -  Current use of drugs known to influence serum calcium (such as thiazide diuretics,\n             teriparatide, calcitonin and multivitamin supplements containing > 400 IU of vitamin D\n             or calcium);\n\n          -  Current use of digitalis;\n\n          -  Current use of drugs which could influence bioavailability of inecalcitol (such as\n             magnesium-containing antacids, bile-resin binders);\n\n          -  Use of any other experimental drug or therapy or vitamin D supplementation within 4\n             weeks of randomization;\n\n          -  Known HIV;\n\n          -  Patients who are eligible for intensive induction therapy with curative intent;\n\n          -  Refractory congestive heart failure;\n\n          -  Active infection resistant to anti-infective therapy;\n\n          -  Documented pulmonary disease with DLCO ? 65% or FEV1? 65%, or dyspnea at rest or\n             requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm;\n\n          -  Liver cirrhosis Child B or C or acute viral hepatitis;\n\n          -  Current mental illness requiring psychiatric hospitalization, institutionalization or\n             intensive outpatient management, or current cognitive status that produces dependence\n             (as confirmed by the specialist) not controlled by the caregiver;\n\n          -  Uncontrolled neoplasia;
Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside this study
Current enrollment in any other investigational treatment study
Current treatment with oral or parenteral anti-coagulants/antiplatelet agents
History of ocular events related to keratitis or corneal disorders, or any current ongoing active ocular infections.
Current mucositis
Subjects with active HSV-1 infection on current valacyclovir, acyclovir or ganciclovir therapy must be off treatment with any of these agents at least 7 days prior to surgery
Current active treatment in another clinical study.
Current or planned glucocorticoid therapy, with the following exceptions:
History or current diagnosis of Pulmonary Alveolar Proteinosis or Hypoxemia
Current or anti-cancer therapy w/in 4 wks pre-study or w/Grade ?1 side effects not resolved w/in 4 wks pre-study
Presence of another malignancy requiring current treatment that would preclude the use of all of the study treatments or the ability to monitor the natural history of MCD untreated
Current symptom of keratitis or retinopathy at >= grade 2
Current use of statins or fibrates for any time during the 3 months prior to the study
Prior systemic therapy for current diagnosis of HNSCC
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
Presence of current angina;
Investigator determined assessment of current stable disease following completion of at least 4 cycles but no more than 8 cycles, of pembrolizumab monotherapy
Failure or intolerance to at least one prior therapy for the current disease
Patients with prior or current history of digoxin exposure
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
No known prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
No known prior history or current evidence of untreated local gum or oral infection
Patients with equivocal HER2 in situ hybridization results according to current ASCO/CAP guidelines are allowed, as long as the clinician has determined that they should be treated as HER2 negative
Current use of warfarin for any reason; NOTE: if patient can be safely transitioned to another anticoagulant, they may be eligible provided other criteria are satisfied
Patients must not have current evidence of another malignancy that requires treatment
Current active treatment in another clinical study
Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment
Subjects with bleeding diatheses, thrombocytopenia or current anticoagulant use
More than 2 prior relapses (not counting the current relapse being treated on this study)
Current histologically transformed disease.
Current infection
Current anticoagulant therapy; (acetylsalicylic acid [ASA] =< 325 mg per day is allowed)
Patients must have received the current TKI for at least 18 months and not have increased their dose in the last 6 months.
Other malignancy that would interfere with the current intervention
Current progestin-based hormone replacement therapy.
Current treatment with the following antiarrythmic drugs: flecainide, moricizine or propafenone
Current or prior radiation to the left hemithorax
Prior exposure to carboplatin (related to current or past diagnosis)
Patients who are on current long term treatment (? 4 consecutive weeks) with Aspirin, NSAID or Cox-2 inhibitors
Patient on active current treatment of antiplatelet agents (i.e. off-study Aspirin, clopidogrel, ticlopidine)
Current major depression.
Current treatment in another clinical study
Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable;
Current corneal epithelial disease except mild punctate keratopathy.
Current corneal disease except for mild punctuate keratopathy.
Current corneal disease except for mild punctuate keratopathy.
Current use of exogenous testosterone
Patients with a current diagnosis of oral mucositis
History or current evidence of hyperthyroidism that would increase metabolism of itraconazole
Current unstable arrhythmia requiring treatment.
Known past or current malignancy other than inclusion diagnosis, except for:
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Current exposure to household contacts =< 15 months old or household contact with known immunodeficiency
No current or active dermatologic diagnoses that would preclude interpretation of skin toxicities of BKM120 and BYL719
Current or prior HTLV-1 associated inflammatory diseases, including but not limited to myelopathy, uveitis, arthropathy, pneumonitis, or a Sjogren’s disease-like disorder
Patients who are not a candidate for an unrelated donor allogeneic HSCT based on the current institutional BMT program clinical practice guidelines; organ function criteria will be utilized per the current institutional BMT program clinical practice guidelines; there will be no restriction to study entry based on hematological parameters
Current use of more than one antihypertensive medication.
Patients who have any option for other treatment for B-cell NHL at the current state of disease.
History or current evidence of
Current active infectious disease
current or prior IV drug users,
current or prior IV drug users,
Current or planned use of systemic therapy for extracranial primary tumor
Known past or current malignancy other than inclusion diagnosis, except for:
History and/or current evidence of ectopic mineralization/calcification
Agree to allow the sponsor to collect data on all GBM-related treatments received after the patient comes off the current study, and to collect survival data after the patient comes off the current study.
Current history of neoplasm other than the entry diagnosis. Exceptions are:
Current or planned pregnancy within the next three months (females only)
Current use of exogenous hormones
Current use of clobetasol propionate
Patients must not have a known diagnosis of hepatitis B or C; patients with the following risk factors must have hepatitis screening pre-treatment:\r\n* Blood transfusions prior to 1990\r\n* Current or prior intravenous (IV) drug users\r\n* Current or prior dialysis\r\n* Household contact with a hepatitis B or C patient\r\n* Current or prior high-risk sexual activity\r\n* History of jaundice
Current indwelling urinary stent
Current treatment with sirolimus AND either cyclosporine or tacrolimus.
Subjects with a past or current diagnosis of another malignancy that will interfere with conduct of the trial; patients with past or current cancer diagnoses other than ACC are allowed to enroll if the investigator believes it will not interfere with trial conduct
No prior therapy with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition
sexual abstinence (only if this is in line with the patient's current lifestyle)
Patients have prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Previous or current history of a myeloproliferative disease
Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study
History and/or current evidence of clinically relevant ectopic mineralization/calcification
Large cell transformation. However, subjects with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes would be eligible.
Current treatment with nitrates
Are unable to discontinue current treatment for CTCL due to risk of progression
Current spontaneous urinary incontinence.
Current or prior chemotherapy
Current use of a prohibitive medication(s)
Current Spigelman Stage 3 or 4. (Refer to Appendix A for Modified Spigelman Score and Classification table).
A history of AEs with prior interleukin (IL)-2 or Interferon will not preclude subjects from entering the current study
Current enrollment in any other investigational treatment study
Prior therapy for advanced malignancy with no current curative option
Current uncontrolled hyperthyroidism
Current carcinoma of the breast
current symptomatic radiation proctitis requiring creams;
Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw
Duration and extent of current episode of AA
Current use of FWGE
Current use (within 10 days of day 1) of megestrol acetate.
Current anticoagulant therapy (acetylsalicylic acid [ASA] =< 325 mg per day allowed)
History of current or prior medical problems that the investigator feels will prevent administration of therapy or assessment of response due to excess toxicity
Current use of drugs with known cardiotoxicity
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
Any other current malignancy
Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
Known past or current malignancy other than inclusion diagnosis, except for:
Current (within last 3 months) use of radiation for breast or other malignancy
Any other current malignancy
Current mucositis.
Current enrollment in another clinical study.
Current use of any platelet functioning inhibitors (including aspirin) within 14 days of first on-study thrombokinetic study
Current unstable ventricular arrhythmia requiring treatment
Current or recent (within 6-months) use of lipid-lowering medication
Other current malignancy than the disease under study
Current or planned glucocorticoid therapy, with the following exceptions:
Current diagnosis of primary cutaneous ALCL (those with systemic ALCL are eligible)
History or current evidence of hyperthyroidism that would increase metabolism of Itraconazole
Current or recent pregnancy (within 12 months),
Current diagnosis for depression, including treatment with an SSRI.
Known or suspected current diagnosis of non GCTB giant cell-rich tumors
Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Untreated current severe depression; currently treated depression is permitted if treatment is stable
Current psychotherapy (regular appointment[s] with a psychologist, counselor, or therapist within the last 30 days)
Current use of tobacco cessation medications
History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)
Recent or current participation in educational/behavioral intervention study with similar focus
Current smokers
Active and current use of illegal recreational drugs
Current venous thrombosis in either upper extremity or be on current anticoagulant therapy
Current (weekly) use of cannabis
Previous or current neurologic disease affecting the lower hemithorax or below
Patient is being treated with oxymetazoline for allergic rhinitis or has a disorder or current medication use likely to adversely affect normal functioning of the nasal mucosa
Current use of cytotoxic or immunosuppressive drugs
Consistent with previous chemoprevention adherence research, patients will be excluded due to the presence of the following psychiatric conditions:\r\n* A lifetime history of dementia (ICD 10 codes F01-, F02-, F03-, F04-);\r\n* A lifetime history of a psychotic disorder (ICD 10 codes: F20-F-29);\r\n* A current diagnosis of a manic episode (ICD 10 codes F30-);\r\n* Current uncontrolled major depressive disorder (ICD 10 codes F33-);\r\n* A current diagnosis of any mental and behavioral disorders due to psychoactive substance use (excluding nicotine-related diagnoses) (ICD 10 codes: F10- F19-, except for nicotine-related diagnoses); and,\r\n* Current intoxication
Current treatment with pregabalin
Current vaginal infection
Current use of insulin or sulfonylureads for glycemic control, or history of ketoacidosis
Patients who are current meditation practitioners
Current or previous neurological disease, which may adversely affect swallowing
Current use of antipsychotics
All subjects must be willing to be monitored for adequacy of nutritional intake during the intervention, as is the current standard of clinical practice
Current or planned use of cyclosporine, anticoagulants, insulin, oral or injectable vitamin D doses over 4,000 IU/day, or tamoxifen
Current use of (other N-methyl D-aspartate [NMDA] antagonists) amantadine, ketamine, or dextromethorphan
Current engagement in yoga practice >= 1 day per week
Current heterosexual or lesbian sexual partner
Current/recent (prior 12 months) pregnancy
ONCOLOGIST: Planning to leave their current practice setting for other employment in the next 3 months
ONCOLOGY NURSE: Planning to leave their current practice setting for other employment in the next 3 months
No current chemo or radio-therapy
Current or planned use of methoxyflurane, oral contraceptives, isotretinoin, penicillin, or ergot alkaloids
No current diagnosed untreated or unresolved oral candidiasis or oral herpes simplex virus (HSV) infection
No current use of glutamine or sucralfate powders at the time of registration (no washout required)
Current enrollment in any other trial that entails the concurrent administration of any other agent designed to enhance postoperative recovery
Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia
Known current vaginal infection
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Current use of anti-cancer cytotoxic chemotherapeutic agents
Any current axis I diagnosis
Deafness, current meditation practice (> 2 episodes or > 1 hour total, weekly), and current enrollment in a stress reduction program
Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
Previous or current neurologic disease affecting the lower hemithorax or below
Patients who are current smokers
Patient has not yet started current course of RT
Current untreated oral candidiasis, oral herpes simplex virus (HSV) infection, or oral mucositis
Current or planned use of other agents for treating hot flashes
Current or planned use of any type of antidepressants
Patient's current participation in a tobacco cessation program
Current skin disease or fungal infection of the feet;
Current use of tobacco/tobacco-containing products;
Have no current doctor's diagnosis of anal condyloma, hemorrhoids, fissures, or anal cancer
Current use of thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) that will be continued on study
current known Methicillin-resistant Staphylococcus Aureus (MRSA) colonization;
current known Vancomycin Resistant Enterococcus (VRE) colonization;
current known immunologically-deficient disease conditions (not including recent chemotherapy);
Current diagnosis or history of cardiac pre-excitation syndromes (e.g. Wolff-Parkinson-White)
Current participation in another cancer chemoprevention study
Endorsing current suicidal ideation or intent
Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season
Endorse current psychosis.
Current use of tobacco cessation medications.
Current use of a retinol containing agent or any retinoid analogue drug within the last 30 days
Eligible participants for focus groups include current or former smokers who are between 55-80 with a 30 pack­-year history
Current systemic use of medications known to interact with statins and potentially increase toxicity, including (e.g., gemfibrozil, cyclosporine, clarithromycin, colchicine, niacin and fibrates)
Current or planned pregnancy
Current or prior advanced adenomas
Current use of rifampin and digoxin
Current or planned pregnancy
Willing and able to maintain current dietary behaviors for the duration of the study
Asymptomatic current or former smokers (having stopped within the last 20 years)
Current or planned use of immunomodulators including: infliximab, 6?MP (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs
Any other current or previous malignancy
Current use of anti-coagulants
Current narcotic use
Current or planned pregnancy within the next three months (females only)
Current use of nicotine replacement therapy (NRT)
Current use of >= 3 alcoholic drinks/day
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Current or history of anal or peri-anal carcinoma
Current treatment with bisphosphonates (as of time of enrollment)
Current treatment with the anticonvulsant depakote (at time of enrollment)
Malignancy other than current disease under study
Current use of gabapentin or venlafaxine for hot flashes
Any patient with a current case of cellulitis
Ileostomy or hepatic resection during current cytoreductive surgery
Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (e.g. current gallstone disease, alcoholism)
Patients who have already started treatment for the current malignancy
Previous inclusion in the current study
Patient undergoing current or recent treatment within past 6 weeks or scheduled for any treatment that could results in changes of lesion appearance between the two study examinations. This would include, but not restricted to, the following: current or recent radiation therapy, surgery, starting or recent chemotherapy.
Current treatment with steroids (must be discontinued 1 week before starting IFN gamma)
Current ingestion of broccoli sprout extract, which may confound study results
Current or recent treatment for any malignancy within the last one year, which may affect biomarkers
Current diagnosis of gastroesophageal reflux disease (GERD) with grade >= 3
History of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder) (Arm 3 only)
Current use of therapy to treat a primary cancer other than melanoma
Patients who have an option for other treatment for B-ALL at the current state of disease.
Current active infectious disease.
For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no known prior or current evidence of any metastatic involvement of distant organs
Patients may not be receiving investigational agents at time of registration, or at any time while on study and during the 4 weeks preceding enrollment
Participants should not have received any other investigational agents nor have participated in an investigational trial within the past 4 weeks
Use of any other investigational or study agents
Use of investigational cancer agents within 6 weeks prior to diagnosis
Patients must not receive any other investigational agents while on study or within four weeks prior to registration
Other anticancer agents and investigational agents should not be given while the subject is on study treatment
Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration
Investigational agents from previous clinical study within 4 weeks
Prior receipt of any investigational immunotherapy. Subjects may have received agents that have local health authority approval for the disease indication
Participants cannot receive treatment with any other investigational agents during protocol therapy
No chemotherapy, other investigational agents within 14 days of study treatment
Patients may not have received any other investigational agents within the last 14 days at the time of treatment start
Exposure to any other anti-leukemic therapy (except hydroxyurea) within 2 weeks before the first dose of study treatment (including investigational chemotherapy regimens involving approved agents)
Current or anticipated use of other investigational agents during the study
Receiving other investigational agents or not yet completed 30 days since completion of an investigational study
Subjects may not be receiving any investigational agents within 30 days prior to start of study treatment
Patients must not have ongoing treatment with any other investigational agents =< 14 days prior to registration
No other investigational, biologic or chemotherapy agents, localized ablation or chemoembolization for 4 weeks prior to study entry
Patients who are receiving any other investigational or chemotherapeutic agents will be excluded; please contact the study principal investigator (PI) if a patient has received an investigational or chemotherapeutic agent in the past
Participant has used investigational agents within 4 weeks of randomization.
Prior treatment with FR-targeting investigational agents is not allowed
Participant receiving any other investigational agents within 30-days of enrollment nor during study participation
Patients may not be receiving any other investigational agents; (i.e. 28-day washout period from prior investigational drug is required)
Current or anticipated use of other investigational agents or marketed anticancer agent while on study
Current enrollment in another clinical study involving treatment and/or is receiving an investigational agent for any reason, or use of any investigational agents within 14 days of initiating study treatment.
Receipt of any chemotherapy, biological therapy or investigational agents within 3 weeks prior to study registration
Other investigational agents: ?4 weeks
No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents within 8 weeks of study entry
Patients who had therapy with one of the investigational agents more than 1 month prior to enrollment in whom tumor genotyping show assignment to the same investigational agent
Subjects may not receive any other concomitant investigational agents
Subjects who are receiving any other investigational agents. Prior immunotherapy, topotecan and temozolomide are allowed
Prior treatment with folate receptor (FR) targeting investigational agents is allowed for dose escalation provided that such treatment was not discontinued due to adverse events; prior FR-targeting investigational agents are not allowed for patients in the expansion cohort
Subjects who require warfarin, anti-cancer therapeutics or investigational agents
Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
Participants who received investigational agents, other than investigational antiretroviral agents for HIV, within the 4 weeks before randomization, unless approved by the study chair
Use of any other investigational agents within 30 days of starting study treatment
Administration of investigational agents within 28 days prior to treatment initiation
Current or anticipated use of other investigational agents
Prior BCMA-directed investigational agents at any time
Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.
Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.
Patients may not be receiving any other investigational agents; a 2 week wash-out period for investigational agents is required before registration
Concomitant use of other investigational agents.
Any previous treatment with a DDR agent, including any of the investigational agents
No investigational agents within 2 weeks prior to first study treatment.
Patients receiving any other investigational agents; any prior investigational agents must be stopped at least 14 days (2 week washout) prior to registration
Patients should not have received any other investigational agents within the past 4 weeks
Receipt of Investigational agents within 28 days prior to first dose of protocol therapy.
Subjects must not have had any prior investigational agents or devices within 4 weeks of beginning study drug
Treatment with other investigational agents within 30 days of day 1
Previous immunotherapy or investigational agents within 6 months of first administration of study drug
Patients are permitted to receive investigational imaging agents while on study
Previous immunotherapy or investigational agents within 6 months of first administration of study drug
Patients receiving any other investigational agents or whom have received recent treatment for colorectal cancer (radiation within the previous two weeks, chemotherapy or investigational therapy within the previous four weeks)
Patients receiving any other investigational chemotherapeutic agents within 28 days prior to the first dose of trial treatment
Subjects receiving any other investigational or standard antineoplastic agents
Receipt of any other investigational agents within 14 days prior to study treatment
Use of any investigational agents within 21 days of registration.
Current or anticipated use of other investigational agents; NOTE the following clarification for this study:\r\n* Prohibited concurrent therapy: \r\n** Participation in clinical trials with other investigational agents, not included in this trial, within 14 days of the start of this trial until 2 weeks after subject has received the last dose of bortezomib for mobilization\r\n** Hypersensitivity to bortezomib, boron or mannitol or G-CSF
Use of any of the following after transplantation and prior to starting study therapy for cohort 3:\r\n* Investigational agents/therapies\r\n* Anti-leukemic agents given as post-transplant maintenance therapy (e.g., subcutaneous or oral 5-azacytidine or FLT3 inhibitors for maintenance)
Use of any active treatment for relapse/refractory AML including but not restricted to chemotherapy, targeted agents, hypomethylating agents or investigational drugs; use of hydroxyurea up to 6g per day for cytoreduction is allowed for a maximum of 15 days prior treatment
Participation in any other investigational study or use of any other investigational agents within 30 days prior to study entry
JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): patients may not be receiving any other investigational agents
At least 3 weeks must have passed since any of the following: systemic corticosteroids, immunotherapy (for example, T-cell infusions, immunomodulatory agents, interleukins, MCC vaccines, intravenous immunoglobulin, expanded polyclonal tumor infiltrating lymphocytes [TIL] or lymphokine-activated killer [LAK] therapy), pentoxifylline, other small molecule or chemotherapy cancer treatment, other investigational agents or other systemic agents that target Merkel cell carcinoma
Subjects must not have received any investigational agents within 30 days of study entry
Subjects requiring or using other investigational agents while on treatment in this trial.
Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 30 days from first receipt of study drug
Use of any investigational agents within 30 days prior to enrollment and for the duration of the study
Subjects may have received any other investigational agents or chemotherapy as long as they are eligible for SABR and surgery
Current therapy with any other investigational agents.
Current or anticipated use of other investigational agents
Chemotherapeutic agents for therapy of AML (note that prophylactic use of these agents is allowed in this study, e.g., methotrexate for GVHD)
Investigational agents/therapies
Past history of other investigational agents
Patients may not be receiving any other investigational agents with the intent to treat the disease (imaging agents are acceptable)
Treatment with chemotherapy, monoclonal antibodies or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial
Current use (or planned use during the treatment period) of other investigational agents, or biological, chemotherapy, radiation or other anti-tumor therapy
Investigational compound within 4 weeks of enrollment or who are planning to receive other investigational agents while participating in this study
Patients must not have received other investigational agents within 14 days of initiation of the conditioning regimen
Ongoing use of investigational agents or use of investigational agents within the last four weeks
Are being treated with other investigational agents.
Subjects receiving any other investigational or standard antineoplastic agents
Patients must not have received any investigational agents within 21 days of study entry
Must not be receiving any other investigational agents within 14 days of first dose of azacitidine (day 7)
Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 4 weeks
-  Investigational Agents: Investigational agents within 4 weeks (or 5 half-lives) of PV-10 administration.
Simultaneous primary invasive cancers or patients currently receiving any other investigational agents at time of study enrollment. Patients may have received investigational agents in the past. No washout time period is required.
Subject has received other investigational agents or devices within 28 days prior to first dose of study treatment.
Prior or current use of any investigational or commercially available anti-HCV agents other than interferon or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration
Current receipt of any other investigational agents
Previous treatment with any other investigational agents within 4 weeks prior to MCLA-117 administration;
Patients receiving any other investigational agents or anti-cancer agents within 30 days other than mibefradil dihydrochloride, hypofractionated RT, or corticosteroids as described in this clinical protocol during treatment
No use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents (including intravenous immunoglobulin [IVIG]) within 8 weeks of study entry; note: use of topical, inhaled and intranasal steroid therapy is permitted
no current or prior use of investigational agents within 4 weeks of study entry.
No non-approved investigational agents or procedures ?4 weeks of study entry
Prior treatment with non-chemotherapy investigational agents is permitted
Use of other investigational agents within 6 months prior to enrollment
Concomitant use of other investigational agents
Receiving any other investigational agents within 4 weeks of beginning study treatment
Subjects receiving any other investigational or standard antineoplastic agents
Patients who have received any other investigational agents within the preceding 4 weeks
Treatment with other investigational agents within 30 days of day 1
No investigational agents within 4 weeks from initiation of study treatment
Patients must not receive any other investigational agents while on study or within four weeks prior to randomization
Current or anticipated use of other investigational agents
DOSE EXPANSION COHORT: Current or anticipated use of other investigational agents while participating in this study
Subjects must not have received any investigational agents within 30 days of study entry
Therapy with other investigational agents within 4 weeks of treatment initiation on this trial
Any other investigational agents within the past 4 weeks
Ongoing use of any other investigational or study agents
Patients may not be receiving or have received any other  investigational agents during or within 1 month prior to treatment with NFV
Current or anticipated use of other investigational agents
Patients who have received any other investigational agents within the last 4 weeks
Patients must NOT be receiving any other investigational agents concurrently and must not have received any other investigational agents =< 4 weeks prior to registration
PHASE II: Patients must NOT be receiving any other investigational agents concurrently and must not have received any other investigational agents =< 4 weeks prior to randomization
Patients may not be receiving any other investigational agents within 4 weeks of starting the study treatment and during the study period
Patients must not receive any other investigational agents during the period on study or the four weeks prior to entry
Current use of any investigational agents
Patients may not be receiving any other investigational agents at time of study entry or at any time while on study or be on another investigational agent that can impact on the primary clinical outcome analyses or has known pharmacodynamics or pharmacokinetic effects on AAT
Treatment with other investigational agents
Patients must not be planning to receive any other investigational agents during the course of protocol treatment
Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks
Active treatment with any other investigational agents
Patients may not be planning to receive any other investigational agents
Patients must not be planning to receive other anti-cancer agents including investigational agents while on protocol treatment
Use of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and other red blood cell hematopoietic growth factors, and within 28 days prior to randomization
Received other investigational agents within 30 days prior to the start of the conditioning regimen
Patients must not have used cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 8 weeks of randomization
Patients may not have received any other investigational agents within 4 weeks of study entry
Subject who is receiving or has received any other investigational agents within 28 days prior to day 1 of treatment in this study; in addition, day 1 of the study treatment should be at least 14 days after prior chemotherapy
Patients with any number of prior therapies with anti-angiogenic agents or immunotherapy with the exception of any previous anti-CTLA-4 directed agents are allowed; a 2 week washout period is required for all agents, except for bevacizumab where a 4 week washout is required
Subjects who are receiving or have received any other investigational agents within 28 days prior to day 1 of treatment in this study
Concomitant use of other investigational agents
Current or anticipated use of other investigational agents
Current or past use of investigational agents within 4 weeks of study enrollment
Other investigational agents within 21 days prior to study treatment.
Use of any other investigational agents
Current use of other investigational agents
Use of investigational agents within 30 days
Receipt of any other investigational agents within 4 weeks preceding the start of study treatment
Patients may not be receiving any other investigational agents\r\n* Note: a wash-out period of 2 weeks prior to registration is required for any patient to be enrolled in the study
Use of any other investigational agents
Participants should not have received any other investigational agents nor have participated in an investigational trial within the past 4 weeks
Prior investigational agents =< 4 weeks prior to registration
Use of investigational agents of any kind within 30 days before study treatment
Previous treatment with a camptothecin derivative (eg., irinotecan, topotecan, and investigational agents including but not limited to exatecan, rubitecan, gimatecan, karenitecan, SN38 investigational agents, EZN 2208, SN 2310, and AR 67) is not allowed
Treatment with chemotherapy, monoclonal antibodies, biological agents (e.g. Ibrutinib) or other than the investigational agents during the time of participation in this trial
Other investigational agents =< 4 weeks prior to registration/ randomization
At least 3 weeks since prior biologics or investigational agents
Prior use of other investigational agents to treat the brain tumor
Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents
Current or anticipated use of other investigational agents while participating in this study
Receipt of any other investigational agents within 14 days prior to study enrollment
Anti-tumor therapy (i.e. chemotherapeutics or investigational agents or immunotherapy) within 4 weeks prior to enrollment
Treatment with other investigational agents =< 14 days of registration
Participants may not be receiving any other investigational or commercial agents or therapies other than those described in this protocol to treat their malignancy
Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of CMML within 28 days of the first day of study drug treatment
Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks of Day 1
Patient must not have received any other investigational agents within 14 days prior to study enrollment
Exposure to chemotherapy, radiotherapy, biologics or investigational agents within 3 weeks prior enrollment in the study
Current or anticipated use of other investigational agents
Subjects receiving other investigational agents thirty days prior to study treatment or during treatment
Patients may not be receiving any other investigational agents; any prior investigational products must be stopped at least 14 days (2-week washout) prior to registration
Subjects may not receive any other concomitant investigational agents
Treatment with other investigational agents in the prior 4 weeks.
Use of investigational agents within 4 weeks prior to enrollment
Any investigational agents
Treatment with other investigational agents within 30 days of day 1
Patients who are using other investigational agents or who had received investigational drugs =< 4 weeks prior to study treatment start
Receiving any other investigational agents including those for symptom management
Patients must not have received any other investigational agents within 30 days prior to vaccination.
Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator
Immunomodulatory agents within 7 days
Patients who are receiving any other investigational agents or commercial agents with the intent to treat the malignancy
Other investigational agents: ?4 weeks
Current use (or planned use during the treatment period) of other investigational agents, or biological, chemotherapy, radiation or other anti-tumor therapy
Treatment with other investigational agents within the prior 7 days prior to the 1st dose of AbGn-168H (neihulizumab)
Patient should not be part of another trial testing other investigational agents or devices
Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exception of androgen ablating agents (for patients with prior prostate cancer)
Patient must not have received treatment with other investigational agents within the last 4 weeks
Patients must have discontinued immunotherapy or other systemic therapy including investigational agents at least 4 weeks prior to entering the study and have recovered from adverse events due to those agents. Patients must agree to not receive any other investigational agents during study participation.
Subjects who have received investigational agents must wait at least 4 weeks
Patients may not receive any other anti-neoplastic or investigational agents within 3 weeks of study enrollment; patients may not be receiving any other investigational agents during treatment on protocol
Administration of any investigational agents within 30 days before study entry
Current receiving any other anti-neoplastic investigational agents
Current therapy with other investigational agents.
Subjects who have received any other investigational agents within 30 days of first lithium dose
Prior anti-leukemia therapy within 14 days of enrollment for classical cytotoxic agents, and within 5x the half-life for other investigational agents
Chemotherapy, biological therapy or investigational agents (except EGFR TKIs) within 4 weeks
Receiving any other investigational agents simultaneously or within 3 weeks following ablation procedure
Patients may not be receiving any other investigational agents; a minimum 4 week “washout” period is required
Use of investigational device or agents within 2 weeks of enrollment date.
Investigational agents/therapies
Investigational agents within 4 weeks of randomization.
Use of other investigational agents within 6 weeks of day 1 of protocol therapy
Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea as defined in protocol
Investigational agents within 4 weeks before start of study therapy
Treatment less than two weeks prior to enrollment with other systemic experimental therapies or antineoplastic agents, with the exception of hydroxyurea and intrathecal chemotherapeutic agents
Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible
Investigational agents within 4 weeks of initial study treatment.
Patients may not use any of the following therapies during the study:\r\n* Any non-study anti-cancer agent (investigational or non-investigational)\r\n* Any other investigational agents\r\n* Any other (non-CA184024 related) CTLA-4 inhibitors or agonists\r\n* CD137 agonists\r\n* Immunosuppressive agents\r\n* Chronic systemic corticosteroids\r\n* Any non-oncology vaccine therapies used for the prevention of infectious diseases (for up to 30 days prior to or after any dose of study drug)
Patient is currently receiving or has received within the last month prior to Cycle 1 Day 1 (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin) other chemotherapeutic, hormonal, or investigational anti-cancer agents with the exception of gonadal suppression agents and bisphosphonates for osteoporosis and skeletal metastases which may be continued while on study
Use of investigational agents, with the exception of gemtuzumab ozogamicin, within 30 days
Systemic anticancer treatment (including investigational agents) or radiotherapy less than 2 weeks before the first dose of study treatment (<=4 weeks for large molecule agents).
No restrictions on use of other investigational agents
Current or anticipated use of other investigational agents
No restrictions regarding use of other investigational agents
Patients must not have received any investigational agents within 30 days prior to commencing study treatment
Patients who are receiving other investigational agents will be permitted on study, at the discretion of the principal investigator
Participants who received any other chronic (defined as more than 50% of the time in the last 6 months) systemic immunomodulatory agents (replacement doses of steroids for adrenal insufficiency are permitted or treatment with prednisone =< 5 mg/day); receipt of investigational agents within the 4 weeks before randomization enrollment, other than investigational antiretroviral agents for HIV and investigational or approved agents for hepatitis C, are also exclusionary
Use of any other investigational agents =< 12 weeks prior to pre-registration
Current use of any other investigational agents
Active use of any other investigational agents
Current use of any other investigational agents
Current use of any other investigational agents
Current use of any other investigational agents
Receipt of any other investigational agents =< 3 months prior to randomization, except innocuous agents with no known interaction with the study agents (e.g., standard dose multivitamins or topical agents for limited skin conditions), at the discretion of the protocol lead investigator at each participating site
Individual may not be receiving any other investigational agents, antiplatelet agents (e.g. aspirin, clopidogrel [Plavix or others]), anticoagulants (e.g. heparin or heparinoids, Coumadin, or others), methotrexate, lithium
Receiving any other investigational agent =< 3 months prior to registration/randomization, except innocuous agents with no known interaction with the study agent (e.g., standard dose multivitamins or topical agents for limited skin conditions)
Patients may not be receiving any other investigational agents; any prior investigational therapeutic products must be stopped at least 28 days (4 week washout) prior to treatment start
Ongoing therapy with other investigational agents
Have received other investigational agents within the past 3 months (preceding the time of registration)
Receipt of any investigational agents within 30 days prior to commencing study treatment
Participants may not receive any other investigational agents within 30 days of enrollment nor during study participation
There will be no restrictions regarding use of other investigational agents
There will be no restrictions regarding use of other investigational agents
Other on-going cancer therapy or investigational agents (except MVT-5873 )
Patients must not receive any other investigational agents while on study
Patients should not be taking other investigational agents
Current use of any investigational agents
Subject has had no use of investigational agents, with the exception of FLT3 inhibiting agents during induction and/or consolidation therapy, within the prior 4 weeks.
Patients should not be taking other investigational agents
Current receipt of any other investigational agents or any additional anti-cancer agents for this or any other disease
At the time of registration, all subjects must be removed >= 28 days from any investigational agents
Ongoing treatment with any other investigational agents
Receipt of any other investigational agents or any additional anti-cancer agents
Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks of Day 1
Patients who are receiving any other investigational agents; a minimum of 4 weeks wash-out period is required for eligibility; please contact principal investigator, Dr. Swati Kulkarni for further clarification
Treatment with other investigational agents less than 14 days prior to study entry.
Patients receiving any statin except pravastatin or rosuvastatin
The patient requires statin therapy. Patients who are taking a statin and are considered appropriate to discontinue treatment, must discontinue the statin at least 5 days prior to starting study therapy.
History of allergic reaction or intolerance to statin treatment
Currently receiving statin therapy or have received any statin therapy within the last 3 months
Patients must be off all \statin\ drugs for ?2 weeks prior to initiation of therapy.
Use of statin drugs or other medications known to associate with rhabdomyolysis; these drugs must be discontinued at enrollment
Statin use in the last 6 months
Patients who have been on a statin other than simvastatin within 2 weeks of starting treatment on current study; these include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, and rosuvastatin; if patient is on statin, will need to stop treatment 2 weeks prior to starting treatment on study
Patients currently treated with metformin or a statin or who have been treated with metformin or a statin in the past 6 months are ineligible for this study
Ongoing anticoagulant, statin and/or anti-platelet therapy
Current use of a statin
Diagnosis of cardiovascular disease (CVD) with or without current statin use
The allogeneic PBSC donor has a contraindication to statin treatment
DONOR: Current use of statin drug
Statin use or statin use is indicated based on guidelines
Prior or current use of statin medication
The allogeneic PBSC donor has a contraindication to statin treatment
Current use of statin medication or statin use within 12 months of screen 1 visit
Current use of statin therapy
Are currently taking a statin or have taken a statin in the past 6 months or have a history of an allergic reaction or intolerance at any time to a statin
Subjects receiving any investigational drug concurrently.
Subjects receiving any investigational drug concurrently.
Subject is enrolled (concurrently) in another investigational study, with the exception of the follow-up period of another investigational study in which no anti-cancer therapy is being administered and where only data are being collected;
Patients who are receiving any other investigational agents concurrently; palliative radiation therapy will be allowed as long as the patient meets all other eligibility criteria
Patients who are receiving any other investigational agents concurrently
Patients who are receiving any other investigational agents concurrently
Patients who are concurrently receiving any other investigational agents
Patients who are receiving any other investigational agents concurrently
Subjects may not be enrolled concurrently on other treatment studies
Subjects concurrently receiving any other investigational agents within 2 weeks prior to the first study treatment
Subjects must not be concurrently receiving disease-modifying therapy in another therapeutic investigational study
Treatment with another investigational agent currently or within 21 days prior to enrollment; patients may participate in other non-treatment studies concurrently if it will not interfere with participation in this study
Patients may not be on any other treatments for their cancer aside from those included in the protocol; patients may not undergo another form of treatment concurrently with this study
Patient may not be concurrently enrolled in another investigational drug treatment study
Participation in another investigational trial concurrently or within 30 days
Participation in another investigational study concurrently or use of another investigational drug within 6 months prior to administration of the first study vaccination;
Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy.
Patients concurrently receiving any other investigational agents
Patient may not be concurrently enrolled in another investigational drug treatment study
Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy
Enrollment concurrently in another investigational drug study or within 4 weeks of registration
Participation in other investigational studies concurrently if these therapies include a therapeutic intervention
Investigational drug use within 28 days of the first dose of PLX3397 or concurrently
Subjects who are concurrently receiving any other investigational agents
Patients who are receiving any other investigational agents or anticancer therapy concurrently or within 4 weeks (ie 28 days)
concurrently use other anticancer or experimental treatments
Subjects may not be receiving any other study agents concurrently while on this study
Patients may not be receiving any other investigational agents concurrently with study treatment
Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy
Patients may not be on any other treatments for their cancer aside from those included in the protocol; patients may not undergo another form of treatment concurrently with this study
Concurrently receiving treatment with calcineurin-inhibitor plus sirolimus (either agent alone is acceptable).
Investigational drug use within 28 days of the first dose of PLX3397 or concurrently.
An investigational drug administered for the diagnosis of seminoma given concurrently or within four weeks of the first fraction of proton therapy administration
Patients who are concurrently participating in any other experimental studies that could affect the primary endpoint of this study
Patients may not be on any other treatments for their cancer aside from those included in the protocol; patients may not undergo another form of treatment concurrently with this study
Patients who are receiving any other investigational agents concurrently
Is concurrently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo.
Concurrently receiving any other concomitant anticancer or experimental drug therapy
Treatment with another investigational agent currently or within 14 days prior to enrollment; patients may participate in other non-treatment studies concurrently if it will not interfere with participation in this study
Use of an investigational agent for pain control concurrently or within the past 30 days
Participation in another investigational trial concurrently or within 30 days
May be concurrently receiving endocrine or HER2 directed therapy
Use of an investigational agent for pain control concurrently or within the past 30 days
Patients may concurrently participate in other therapeutic clinical trials
Receiving any agent concurrently with CLT-008 infusion which inhibits cell division (e.g., methotrexate or hydroxyurea)
Participants may not be concurrently receiving any other study agents
Has been treated with an investigational agent within 30 days or six half-lives of its biologic activity whichever is longer, before the start of study. (Patients may not be concurrently enrolled on another trial or concurrently treated with another investigational agent)
Participation in another investigational drug trial either concurrently or 30 days prior to surgery
Patients receiving systemic treatment with any immunosuppressive medication (other than steroids as described above).
Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
Current or prior use of immunosuppressive medication within 14 days prior to the first dose Additional Exclusion Criteria for Arm A
Use of immunosuppressive medication at the time of enrollment
Participants receiving systemic treatment with any immunosuppressive medication (other than steroids as described above)
Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
Patients receiving systemic treatment with any immunosuppressive medication, excepting the above
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
Patients who are taking immunosuppressive medication
Treatment with systemic immunosuppressive medication;
Current or prior use of immunosuppressive medication within 28 days before the first study treatment
Prior medication:
Current or prior use of immunosuppressive medication within 7 days prior to study entry
Current or prior use of immunosuppressive medication within 14 days with some exceptions
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
Patients receiving systemic treatment with any immunosuppressive medication.
Patients who are taking immunosuppressive medication
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083
Current use of immunosuppressive medication at study entry, with the following exceptions:
Current use of immunosuppressive medication at the time of study enrollment.
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study
Current or prior use of immunosuppressive medication within 14 days with some exceptions.
Immunosuppression: Any immunosuppressive medication must be stopped ? 4 weeks prior to enrollment
Concurrent or prior use of immunosuppressive medication with 14 days
Subject use of immunosuppressive medication within 14 days before Cycle 1 Day 1.
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion:
Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:
Patients receiving systemic treatment with any immunosuppressive medication.
Prior medication:
Systemic immunosuppressive medication within 2 weeks prior to study drug
Current or prior use of immunosuppressive medication within 28 days before start of treatment.
Current or prior use of immunosuppressive medication within 14 days of first dose
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
Post-transplant exposure to any novel immunosuppressive medication (e.g., alemtuzumab) within 100 days prior to enrollment
Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product;
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI6383. )
Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736
Current use of immunosuppressive medication at the time of study enrollment.
Ongoing ? Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria. Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551
Concurrent or prior use of immunosuppressive medication within 28 days;
Concurrent or prior use of immunosuppressive medication within 14 days
Use of immunosuppressive medication or systemic steroids within 7 days prior to first dose of MEDI3617
Subjects on concurrent anticoagulant, or immunosuppressive medication
Subjects on concurrent anticoagulant, or immunosuppressive medication
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
Patients with steroid refractory cGVHD cannot have prior exposure to any new immunosuppressive medication in the preceding 2 weeks prior to enrollment
Treatment with systemic immunosuppressive medication