Re-registration Eligibility Criteria (for patients who crossover from arm 1 nivolumab alone to dual agent nivolumab and ipilimumab upon progression)
Patients removed from any immunotherapy for reasons other than progressive disease, including arm 1 single agent nivolumab of A091401, are NOT eligible for re-registration
Patients must have completed a minimum of 10 weeks of single agent nivolumab on arm 1 of A091401 to be eligible for re-registration
Patients must have completed study drug on arm 1 of A091401 (i.e., last dose of nivolumab) =< 12 months of re-registration to crossover dual agent therapy
STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE)
ARM B (AZACITIDINE + NIVOLUMAB)
ARM C (AZACITIDINE + MIDOSTAURIN)
Patients who have been infected with HBV or HCV including those with inactive disease. Additional exclusion criteria for Combination arm PDR001+CJM112
Active candida infection, including mucocutaneous infection or history of invasive candidiasis. Additional exclusion criteria for Combination arm PDR001+trametinib
Ability to take aspirin or other anticoagulation (ARM 3 only)
Recurrent glioma where injection in either arm A or B of the biologic agent would require access and/or considerable spillage into the ventricular system
MK-1454+pembro (liver metastasis/lesions) Arm:
Combination Arm: adequate heart function
Protocol treatment is to begin within 2 calendar days of patient randomization for patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol treatment within 7 calendar days of randomization.
Note: the MRI study is mandatory irrespective of randomization to the experimental or control arm of this study
ARM 1 - AP
ARM 2 - A: ANC: >= 1500/mcL
If a patient fully meets criteria for Arm 1, but has profound hearing loss and the physician feels that the patient should not receive cisplatin, the patient will be eligible for Arm 2
If a patient fully meets criteria for Arm 1, but has a history of solid organ or bone marrow transplant, the patient will be eligible for Arm 2
CLL ARMS (ARM A and ARM C) FOR COMBINATION THERAPY INCLUDING IBRUTINIB or IDELALISIB:
CLL ARMS (ARM A and ARM C) FOR COMBINATION THERAPY INCLUDING IDELALISIB ARM:
ARM A OR C EXCLUSION:
ARM B OR D EXCLUSION:
Patients with a known hypersensitivity to tacrolimus, methotrexate (Arm A or C) or MMF (Arm B or D)
Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm:\r\n* Greater than 2 invasive thoracic procedures\r\n* Poor exercise tolerance\r\n* Greater than 66 years of age
Surgical arm (Arm A) must be predicted pre-operatively to have sufficiently sized tumor to be resected and provide tissue samples for exploratory assessments.
Have a diagnosis of a tumor with evidence of genomic instability on Clinical Laboratory Improvement Amendments (CLIA) certified genomic testing, inclusive of mutations in POLE, POLD1 for arm 1 and in BRCA1 and BRCA2 for arm 2; in arm 2, enrollment of breast and ovarian histologies will be limited to a total of 10 patients
Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)
Evidence of leptomeningeal disease on MRI or in cerebrospinal fluid (CSF) for arm 1; ocular or mucosal disease specifically for patients with melanoma in arm 1
PARPi naive or prior exposure to PARPi therapy (varies depending on Arm 1 and Arm 2)\r\n* Patients in Arm 1 (single agent rucaparib followed by combination upon progression) must be PARPi naive; prior irinotecan is allowed\r\n* Patients in Arm 2 (combination) must have been treated with and progressed on a PARPi previously; prior irinotecan is allowed
Prior Therapy (for patients with R/R PTCL):\r\n* Exposure to any agent targeting PD-1, PD-L1 or CTLA-4\r\n* Previous therapy with any of the drugs contained in the regimen the patient is assigned to receive; in this case, the patient will be enrolled in the next treatment arm that does not contain such drugs, according to the sequence Arm A -> Arm B -> Arm C ->Arm D\r\n* Exposure to biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation therapy within 2 weeks prior to entering the study or lack of resolution of adverse events (AE) due to previously administered antineoplastic therapy to grade 1 or less according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0\r\n* Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab; the following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent for at least 5 days prior to the start of the study drugs\r\n* Prior allogeneic SCT
Only for subjects enrolled in Arm 1 - Neratinib and everolimus: history of hypersensitivity to everolimus.
Only for subjects enrolled in Arm 1 - Neratinib and everolimus: Major surgery =< 28 days prior to treatment with everolimus.
Patients with a history of prior treatment with ipilimumab, anti-programmed cell death protein 1 (PD 1) antibody, or cluster of differentiation (CD)137 agonist therapy are ineligible for the ipilimumab arm, but are eligible for the nivolumab arm
Prior pemetrexed is allowed except Arm A dose level 4 (cisplatin 75 mg/m^2)
Consent to undergo mandatory prostatic core biopsies at the time of fiducial marker placement and 21 days (+/- 7 days) after with or without SD-101 therapy, depending on study arm
Documentation of arm volume measurement by perometer prior to axillary surgery
ARM B ONLY
ELIGIBILITY FOR OBSERVATION ARM
Must have started ADT for metastatic disease within 134 days (for Arm A and B) or within 30 days (for Arm C)
Phase Ia part: advanced solid tumors or metastases including lymphoma localized in the head and neck region or thorax with an indication for fractionated palliative RT (Arm A); or treatment-naïve SCCHN eligible for fractionated curatively intended RT with concurrent cisplatin (Arm B)
ARM B COHORT 3: Patients must not have active clinically significant hemoptysis
ARM B COHORT 3: Patients must not have a central lesion with radiologic evidence of arterial involvement
ARM C COHORT 4: Patients must not have prior cisplatin exposure
Hematological - Absolute neutrophil count (ANC) ? 1.5 x 109/L (Carboplatin Plus Paclitaxel Arm or Paclitaxel Arm) or ? 1.0 x 109/L (Anastrozole Arm)
Hemoglobin (Hb) ? 9 g/dL (Carboplatin Plus Paclitaxel Arm or Paclitaxel Arm) or ? 8 g/dL (Anastrozole Arm)
FOR BOTH ARM A AND ARM B:
Multi-focal or metastatic disease (Arm B)
History of hypersensitivity to crizotinib for vemurafenib/crizotinib arm
Eligibility criteria specific to the control arm:\r\n* Participants must be willing and able to provide written informed consent/assent for the control arm of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT) trial
Eligibility criteria specific to the abemaciclib arm:\r\n* Participants must be willing and able to provide written informed consent/assent for the abemaciclib arm of the INSIGhT trial\r\n* Women of child bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from date of initial dose and for 3 months following the last dose of abemaciclib
Accrual to each treatment arm will include standard risk and poor risk patients, except for Regimen D; all patients on Arm D will be poor risk by virtue of risks of relapse and/or transplant related mortality
Arm 2: Subjects must have received at least one prior therapy and a maximum of three prior therapies. No prior treatment with 5-Azacitidine is allowed in this arm.
Arm 1 and 2 Exclusion:
Inpatient or outpatient with presence of indwelling CVC (ie, totally implantable port, tunneled or non-tunneled CVC, hemodialysis catheter, or peripherally inserted CVC) that has been in place for greater than5 days from which a bloodstream infection has been documented within 96 hours prior to enrollment (and from which an isolate of the baseline pathogen(s) is still available for analysis at the central laboratory) and demonstrates the protocol definition of CRBSI/CLABSI; NOTE: For the treatment arm only (MLT Arm and Control Arm), the CVC is expected to be in place through the end of treatment.
Female subjects of childbearing potential must have a negative urine and/or serum pregnancy test within 5 days prior to randomization (MLT Arm and Control Arm) ;
Carcinoma patients in Arm A or Arm B must have received at least 1 prior regimen of standard of care systemic antitumor therapy for their metastatic disease and experienced tumor progression within 3 months after the last prior administration of the therapy or experienced unacceptable toxicity to these treatments.
Subjects in Arm A and Arm B should have measurable CT evidence of liver metastases or liver lesions that are not treatable by surgical resection or local ablation in consultation with hepatobiliary specialist.
History of liver cirrhosis by radiologic, clinical or laboratory data, or biopsy despite normal liver function tests Phase II Expansion Arm A and Arm B:
ARM A: Willingness to provide all biological specimens as required by the protocol
ARM A: Uncontrolled infection
ARM A: Any corticosteroid use =< 28 days prior to registration
ARM A: Any radioembolization or transarterial chemoembolization (TACE) =< 84 days prior to registration
ARM B: Willingness to provide all biological specimens as required by the protocol
ARM B: Uncontrolled infection
ARM B: Any corticosteroid use =< 28 days prior to registration
ARM B: Any radioembolization or TACE =< 84 days prior to registration
PHASE I STUDY -- ARM A (DOSE LEVEL 1) AND ARM B (DOSE LEVEL 2)
Must be either initiating therapy with romidepsin (Arm A) or currently receiving romidepsin with documented stable disease (SD) or partial response (PR) (Arm B)
At least 14 days and no more than 28 days must have elapsed between the last day of treatment on Arm 1 and registration to Arm 3
Patients randomized to either arm may also co-enroll in phase III trials that compare local therapies, or compare systemic therapies (such as chemotherapy, if randomized to Arm I of S1007)
Patients must be willing to have blood draws for PK/ADA analysis as outlined, should the patient be randomized to the MK-3475 arm
While patients randomized to the standard arm (Arm B, 30-33 fractions) may receive concurrent chemotherapy with carboplatin/taxol at their treating physician’s discretion, patients enrolled to the experimental arm (Arm A, 15 fractions) cannot be treated with concurrent chemoradiation and must not have plans for concurrent chemoradiation therapy; sequential chemotherapy (prior to or after radiotherapy) is allowed for either arm
Chemotherapy given within one week of study registration/enrollment except concurrent chemotherapy may to be given at the investigator’s discretion to patients randomized to the standard arm (arm B, 30-33 fractions)
Eligibility for crossover registration from Arm A (lenalidomide alone) to Arm B (lenalidomide and epoetin alfa):
Patients must show failure to achieve MER (major erythroid response) or have achieved MER but relapsed on Arm A
For patients enrolling onto Arm B (mFOLFIRINOX) or Arm C (FOLFIRI)
For patients enrolling onto Arm D (MM-398 with 5-FU and leucovorin)
Study Arm 1:
Study Arm 2
Study Arm 1
Study Arm 2
Negative tuberculosis quantiferon test for anakinra arm.
Negative serology for histoplasma, blastomycosis, and coccidiomycosis for anakinra arm.
Patients with known hypersensitivity to any of the components of an investigational treatment will be excluded from participation in the corresponding arm but are eligible for participation in other study arm; Patients that have a history of hypersensitivity to rapamycin derivatives will be excluded from participation in the everolimus arm
The first dose of atezolizumab in the crossover arm should be within 42 days of last dose but no less than 21 days from the last dose prior to crossing over
Participants with a history of poor tolerance to either ibrutinib or idelalisib should not be enrolled on the arm containing that drug, but may be enrolled to the other arm; must agree not to share study medication with another person
Have a histologically proven BCC in which curative resection is unlikely without significant morbidity, or have nodal or distantly metastatic disease which has progressed on smoothened inhibitor monotherapy (ARM 1) or has undergone partial response or stable disease on smoothened inhibitor monotherapy (ARM 2); individuals who are intolerant or have medical contra-indication to smoothened inhibitor may be enrolled into ARM 1
Arm 2 ONLY: Surgically operable NSCLC or mesothelioma
ELIGIBILITY FOR TREATMENT ON ARM 1: Evidence of WT1 tumor expression
ELIGIBILITY FOR TREATMENT ON ARM 2: Patients must express HLA-A*0201
ELIGIBILITY FOR TREATMENT ON ARM 2: Evidence of WT1 tumor expression
Failure to achieve at least a MR after the last rituximab-containing therapy. If the subject meets this exclusion criterion and therefore is excluded from the main randomized study, participation in the non randomized substudy (Arm C) may be considered
Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor Eligibility Criteria for Open-label Substudy Treatment Arm C The Inclusion/Exclusion criteria for the substudy (Arm C) are identical to those described above for the randomized study but, to be eligible, subjects need to be considered refractory to the last prior rituximab-containing therapy defined as either
Patients who are randomized to the control arm must not receive therapy based on prior molecular profiling
Part B2 Arm 1 only:
REGISTRATION TO SURGERY (ARM S)
The presence of deletion of the short arm of chromosome 17
CRIZOTINIB PLUS PAZOPANIB ARM A:
CRIZOTINIB PLUS PEMETREXED ARM B, PAXOPANIB PLUS PEMETREXED ARM C, CRIZOTINIB PLUS PAZOPANIB PLUS PEMETREXED ARM D:
Expansion cohort only for arms containing crizotinib: arm A (crizotinib plus pazopanib) and arm B (crizotinib plus pemetrexed) and arm D (crizotinib plus pazopanib plus pemetrexed) but not arm C (pazopanib plus pemetrexed); patients must have anaplastic lymphoma receptor tyrosine kinase (ALK) abnormality including: translocation, ALK amplification, mutation and overexpression as determined by fluorescence in situ hybridization (FISH), immunohistochemistry (IHC),quantitative real-time polymerase chain reaction (qPCR), quantitative reverse transcription (qRT)-PCR, array comparative genomic hybridization or direct sequencing (aCGH); or patients must have a macrophage stimulating 1 receptor (c-met-related tyrosine kinase) (c-Met) abnormality, either c-Met amplification or c-Met mutation or patients must have the c-ros oncogene 1, receptor tyrosine kinase (ROS1) translocation as determined by FISH
Subject must be chemotherapy naive (except Arm D, K, L and M). Prior use of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is acceptable. For Arms D, K, and L, subjects must be non-progressors within 42 days after completion of first-line treatment with ?4 cycles of Platinum Doublet chemotherapy with or without Bevacizumab. See below for Arm M
Patients who have been previously treated with an anti-VEGF agent will be excluded from Arm A and Arm B
Arm A:
CRITERIA FOR ASSIGNMENT TO THE LOW-RISK ARM OF THE PROTOCOL:
Desmoplastic medulloblastoma patients who are >= 3 to < 5 years of age will NOT be eligible for the low risk arm of the protocol
CRITERIA FOR ASSIGNMENT TO THE INTERMEDIATE-RISK ARM OF THE PROTOCOL
Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
Prior treatment with Herceptin (Arm B only)
Pre-registration chemotherapy given within 42 days of treatment (treatment meaning surgery if Arm A, chemotherapy if Arm B)
Karnofsky/Lansky performance scale\r\n* ARM A: > 60%\r\n* ARM B: No limitation
Renal function\r\n* ARM A: Creatinine clearance > 60 ml/min\r\n* ARM B: No limitation
Hepatic function\r\n* ARM A:\r\n** Liver enzymes (< x 3 upper limit of normal [ULN]),\r\n** Bilirubin (< x 2 ULN) and stable in the 30 days prior to TCD boost\r\n* ARM B: No limitation
Cardiac function: \r\n* ARM A: No evidence of uncontrolled heart failure or active angina\r\n* ARM B: No limitation
Pulmonary function\r\n* ARM A: Spontaneous breathing, not requiring ventilatory support\r\n* ARM B: No limitation
Subject currently participating in a clinical investigation that includes an active treatment arm
SELUMETINIB ARM: Platelets < 100 x 10^9/L (100,000 per mm^3)
LAPATINIB DITOSYLATE ARM: LVEF < 50%
Patient must have at least 2 measurable lesions that are >= 1.5 cm in one dimension; one of the lesions, must meet additional criteria a or b depending on the treatment arm:\r\n* For Arm A patient must have at least one lesion that is >= 2.0 cm and is amenable to image-guided cryoablation and multiple vaccine injections as determined by Interventional Radiology (including tumors that can be safely accessed using imaging guidance and treated with minimal risk to adjacent structures)\r\n* For Arm B patient must have one lesion that can be excised for in vitro vaccine preparation
Enrollment into Arm B will be permitted if ibrutinib is considered the standard of care in the clinical practice. EXPANSION COHORT 2 OF ARM C:
Chemotherapy, radiotherapy, investigational anticancer therapy or major surgery within 28 days of Day 1 dosing with the following exceptions: a. Arm A: A minimum 5-day washout after discontinuation of ibrutinib therapy (or other BTK inhibitors) is required; only those subjects without rapid disease progression during the 5-day washout will be allowed to enroll into Arm A. i. Rapid disease progression is defined as follows:
Part I Histologically- or cytologically-confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exist. Part II Arm A have head and neck cancer or K-Ras wild type EGFR expressing colon cancer, Arm B, have non small cell lung cancer, Arm C, have BRAF V600E mutated melanoma and Arm D have HER2 positive breast or gastric cancer that has progressed following one or more treatments for advanced or metastatic disease.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 for Arm A and C subjects and 0-2 for Arm B.
History of severe intolerance to cytotoxic agent(s) given in the assigned arm
Arm C: Patients with CML in CP after failure of 2 FDA-approved TKIs (i.e., Non-Acute group patients)
Patients who have demonstrated intolerance to dasatinib 100 mg daily will not be eligible for Part III/Arm B or C of the study.
Current use of alpha-adrenergic receptor blockers For Combination Arm only:
Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm)
Absolute neutrophil count ? 1500 per microliter Stages I and II, Arm C or Stage II Arm D:
Stage I Arm A: Pregnancy, lactation, or intention to become pregnant or fathering a child during the study
Additionally, for participants in the ibrutinib combination arm (Cohort E), use or consumption of any of the following substances:
Have stable arm LE; LE will be considered “stable” if during the 3 months prior to study enrollment there was no arm infection requiring antibiotics, no change in ability to perform activities of daily living related to LE, and no subjective report of significant persistent changes in limb volume
Current infection or lymphangitis involving the affected arm
Willing to be randomized into either study arm
Ready to use reliable contraceptive procedures Inclusion Criteria Specific to HCC (Arm A and Arm F):
Active hepatitis B (chronic or acute), or hepatitis C (exception for participants in Arm A and Arm F)
Presence of islet cell neoplasms Exclusions Specific to Arm E (Metastatic Esophageal Cancer) (Patients who meet any of the following specific exclusion criteria will be excluded from enrollment in Arm E:)
For all arms except Arm L (pembrolizumab) and Arm M (nivolumab), patients must have failed prior standard curative chemotherapy for their disease; subjects must have failed, be intolerant to, or be ineligible for any potentially curative approved treatment, irrespective of line of therapy
Platelets >= 125 x 10^9/L (for Arm L pembrolizumab and Arm M nivolumab and expansion cohorts for all arms, platelets >= 100 x 10^9/L)
Hemoglobin >= 10 g/dL (for Arm L pembrolizumab and Arm M nivolumab and expansion cohorts for all arms, hemoglobin >= 9 g/dL
Arm C: Patients with a methotrexate allergy are excluded
Patient should be at least 4 weeks removed from surgery or radiation in affected arm
Arm circumference between 22-47 cm
The affected arm must be > 2 cm larger than the unaffected arm; differences of 2 cm or more between the affected and unaffected arm are considered by experts to be clinically significant; each affected arm will be measured in two areas: upper arm and forearm; the larger of the two measures -upper arm or forearm- will be used for analysis
For Arm 1 patients, participation in this study, in the opinion of the treating physicians, will not introduce delays in surgery that would adversely affect the patient
Willing to undergo two surgical procedures (if participant chooses the ISDO arm)
Phase 2 Part: Patients with confirmed diagnosis of MF who meet all of the following criteria: (a) DIPSS of intermediate-1 or higher, (b) Platelet count: ? 75 (monotherapy arm) or ? 100 (combination arm), (c) ANC ? 1.0, (d) Palpable spleen ? 5cm, (e) Peripheral blood blast count <10%, (f) At least 2 symptoms measurable using the MFSAF v4.0, (g) Monotherapy Arm patients: Previously treated with a JAK inhibitor and be intolerant, resistant, refractory or lost response to the JAK inhibitor, (h) Combination Arm patients: Be on a stable dose of Ruxolitinib
Participants who have previously enrolled and received study drugs on arm 1 of this study cannot re-enroll onto arm 1 after being removed from this study, but if they were removed from arm 1 for disease progression, they are eligible to re-register onto this study in order to enroll onto arm 2 of this study if they otherwise meet all of the eligibility criteria for this study; all participants who received an investigational product on a clinical trial, including arm 1 of this study, must wait 21 days prior to course 1 day 1 (C1D1) of this study
Arm 1: Evidence of recurrent or progressive supratentorial tumor, which has shown a > 25% increase in bi dimensional measurements by MRI or is refractory with significant neuro deterioration that is not otherwise explained with no known curative therapy. Arm 2: Clinical presentation of DIPG and compatible MRI with approximately 2/3 of the pons included. Subject should be ? 2 weeks and ? 10 weeks post standard focal radiotherapy (ie, dose of 5400 to 5960 cGy and maximum dexamethasone of 1 mg/m2/day)
Prior use of CC-122 (Arm B)
At least 2 doses of fusion vaccine were produced (Arm A only)
ARM II ONLY: Nonspecific or no evidence for disease on standard imaging modality
ARM III ONLY: Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality; if only soft tissue metastasis, one lesion must measure at least 6 mm or greater; patients must have confirmation of prostate cancer prior to 18F-DCFBC imaging\r\n* Note: a patient who is eligible for one arm, subsequently may cross-over into a different arm
Study Arm 2: Patients previously diagnosed with a non-mucinous epithelial ovarian carcinoma (including serous, clear cell, and endometrioid histologies as well as borderline ovarian tumors) currently undergoing routine surveillance for recurrence, having been diagnosed with recurrence but prior to initiation of chemotherapy; patients from Study Arm 1 will automatically be included in Study Arm 2 as well unless they withdraw consent; finally, patients who have been diagnosed with an ovarian cancer of acceptable histology, who have already undergone surgery or biopsy, but not yet initiated adjuvant chemotherapy are eligible for Study Arm 2
Active substance use disorder (diagnosed or strongly suspected) (Arm 4)
Additional Exclusion Requirements for arm 1 only (nivolumab Plus TAK-580)
Additional Exclusion Requirements for arm 3 only (vedolizumab Plus nivolumab Plus ipilimumab)
Prior treatment with idelalisib;
Prior treatment with idelalisib
Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors.
Prior treatment with idelalisib
Prior treatment with idelalisib (a PI3K inhibitor).
Previous treatment with idelalisib at any time (ZYDELIG®)
Patients with prior treatment with idelalisib.
Has had prior treatment with idelalisib
For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®) ; individuals with malignancies being studied in these protocols must have failed screening in the respective idelalisib protocol
Prior exposure to idelalisib
Prior therapy must include rituximab and alkylating agents.Prior exposure to idelalisib or other PI3K inhibitors is acceptable (except to copanlisib) provided that there is no resistance.
Idelalisib within 2 days prior to leukapheresis
IDELALISIB-SPECIFIC EXCLUSION CRITERIA
Ongoing drug-induced pneumonitis would be exclusion for idelalisib therapy but ibrutinib would be an option
Prior systemic chemotherapy treatment for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib single agent only)
Received one prior line of chemotherapy for metastatic pancreatic ductal adenocarcinoma (Arm: idelalisib + mFOLFOX6 only)
Hepatic: Total bilirubin ? 1.25 x upper limit of normal (ULN) (Arm: idelalisib + nab-paclitaxel ); total bilirubin ?1.5 x ULN (Arm: single agent idelalisib and Arm: idelalisib + mFOLFOX6); aspartate transaminase (AST) (SGOT), alanine transaminase (ALT) (SGPT) < 2.5 x ULN, and albumin > 3.0 g/dL
Presence of peripheral neuropathy ? Grade 2 (Arm: idelalisib + nab-paclitaxel and Arm: idelalisib + mFOLFOX6)
Prior therapy with idelalisib
Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible
Prior exposure to idelalisib