ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomization
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed treatment with any investigational agent >= 30 days prior to randomization for protocol therapy, if applicable
STEP I: Hemoglobin >= 8 g/dL (obtained within 28 days prior to randomization)
STEP I: Bilirubin =< 1.5 mg/dL (obtained within 28 days prior to randomization)
STEP II: Hemoglobin >= 8 g/dL (within 28 days prior to randomization to Step II)
STEP II: Platelet count >= 75,000 cells/mm^3 (within 28 days prior to randomization to Step II)
STEP II: Absolute neutrophil count >= 1000 cells/mm^3 (within 28 days prior to randomization to Step II)
STEP II: Calculated creatinine clearance >= 30 mL/min (within 28 days prior to randomization to Step II)
STEP II: Bilirubin =< 1.5 mg/dL (within 28 days prior to randomization to Step II)
STEP II: SGPT (ALT) and SGOT (AST) < 2.5 times the upper limit of normal (within 28 days prior to randomization to Step II)
STEP 2 RANDOMIZATION
Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to step 2 randomization; eligible patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to step 2 randomization
Platelets >= 75,000/mcL within 14 days prior to step 2 randomization
Hemoglobin >= 9 g/dL within 14 days prior to step 2 randomization
Bilirubin =< 1.5 mg/dL within 14 days prior to step 2 randomization
STEP 2: RANDOMIZATION
After completing one cycle of therapy, patients will be registered for randomization between intermittent and continuous dosing, provided that they were eligible for the initial step 1 registration and satisfy the following criteria
REGISTRATION STEP 2-RANDOMIZATION: Patients must not be known to have AML in the CNS
REGISTRATION STEP 2-RANDOMIZATION: Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 42 days prior to randomization (registration Step 2); reports of the results must be submitted
REGISTRATION STEP 2-RANDOMIZATION: FLT3 results will be used for stratification purposes at the time of randomization; E-mail notification that FLT3 specimens have been processed must be received prior to randomization (registration Step 2)
REGISTRATION STEP 2-RANDOMIZATION: Prior treatment with hydroxyurea is permitted; prior all-trans retinoic acid (ATRA) for suspected APL and prior intrathecal therapy are permitted, but must plan to be discontinued prior to initiating protocol therapy; patients with signs/symptoms of hyperleukocytosis or white blood cells (WBC) >= 50,000/mcL can be treated with leukapheresis prior to randomization (registration to Step 2)
REGISTRATION STEP 2-RANDOMIZATION: Patients may have received non-intensive therapy for antecedent hematologic disorders, including lenalidomide; patients may have received prior chemotherapy for prior cancers; these therapies must be discontinued at least 5 days prior to randomization (registration to Step 2)
REGISTRATION STEP 2-RANDOMIZATION: Patients must have complete history and physical examination within 28 days prior to randomization (registration to Step 2); history must include autoimmune disease status (to determine whether patient is eligible for Arm B)
All tests for establishing baseline values must be completed within 14 days prior to registration to Step 2 (randomization)
RANDOMIZATION (STEP 1)
RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
STEP II (THERAPY)
PRIOR TO STEP ONE RANDOMIZATION:
PRIOR TO STEP TWO RANDOMIZATION:
STEP 2: RANDOMIZATION
REGISTRATION STEP 1: INITIAL RANDOMIZATION
STEP 2 REGISTRATION (RANDOMIZATION CRITERIA):
RANDOMIZATION (STEP 1)
Patients must have BRAFV600E mutant status documented by a Clinical Laboratory Improvements Amendments (CLIA) certified laboratory on a pathology report prior to Step 2 registration; use of an Food and Drug Administration (FDA)-approved test is preferred although other BRAF tests at a CLIA-certified laboratory will also be accepted \r\n* If a BRAFV600E mutation is known, then the patient must be registered to Step 2 Randomization immediately following Step 1 Initial Registration\r\n* If testing has not been performed locally, BRAFV600E testing must be completed by the central laboratory (lab) prior to Step 2 Randomization; if the specimen does not have a BRAFV600E mutation, the patient is ineligible for Step 2 Randomization
STEP 2 RANDOMIZATION:
Patients with known BRAF mutation must be registered to Step 2 Randomization immediately following Step 1 Initial Registration
Patients must have an electrocardiogram (ECG) within 14 days prior to Step 2 Randomization
STEP 2 RANDOMIZATION REGULATORY CRITERIA:
REGISTRATION/RANDOMIZATION TO STEP 2 - ARMS A, B, C AND D
STEP 2 ENROLLMENT AND RANDOMIZATION: less than or equal to three metastatic lesions and no evidence of disease progression based on RECIST criteria; note that patients that had > 3 metastatic lesions in Step 1 may be eligible for enrollment in Step 2 if the number of metastatic sites is reduced to three or less
STEP 2 ENROLLMENT AND RANDOMIZATION: platelet count >= 100,000/mm^3 within 3 weeks of study entry
STEP 2 ENROLLMENT AND RANDOMIZATION: hemoglobin >= 9 g/dL within 3 weeks of study entry
STEP 2 ENROLLMENT AND RANDOMIZATION: bevacizumab will not be permitted within 2 weeks of the initiation of the radiation therapy course
STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has signed informed consent
STEP 2 (RANDOMIZATION)
PRIOR TO STEP 2 RANDOMIZATION
STEP 2 REGISTRATION (Randomization)
STEP 2: INCLUSION CRITERIA PRIOR TO RANDOMIZATION
STEP 2: EXCLUSION CRITERIA PRIOR TO RANDOMIZATION