Idelalisib in Treating Patients with B Cell Malignancies after Donor Bone Marrow Transplant

Inclusion Criteria

• Patients having undergone alloHSCT to treat a B-cell derived hematologic malignancy: accepted alloHSCT regimens include: myeloablative or reduced intensity conditioning from any donor (matched, partially mismatched or cord) and any source (peripheral blood, bone marrow, or cord)
• Total bilirubin (T bili) =< 1.5 mg/dL except for patients with Gilbert’s syndrome or hemolysis
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 2.5 X upper limit of normal (ULN)
• Alkaline phosphatase (alk phos) < 2.5 X ULN
• Karnofsky performance score >= 40
• Eastern Cooperative Oncology Group (ECOG) =< 3
• For women of childbearing potential, a negative serum or urine pregnancy test with sensitivity less than 50 mIU/m within 72 hours before the start of study medication
• Use of two forms of contraception with less than a 5% failure rate or abstinence by all transplanted patients for a minimum of 1 month after the last dose of Idelalisib; for the first 60 days post‐transplant, transplant recipients should be encouraged to use non‐hormonal contraceptives due to the potential adverse effect of hormones on bone marrow engraftment
• Ability to receive oral medication
• Ability to understand and provide informed consent

Exclusion Criteria

• ECOG > 3 (Karnofsky < 40%)
• ALT, AST > 2.5 ULN or total bilirubin > 1.5 ULN (not attributable to Gilbert’s)
• Women who are pregnant or breastfeeding
• Exclude if patient has cirrhosis or is currently being actively treated for hepatitis C
• History of positive human immunodeficiency virus (HIV)‐1 or HIV‐2 serologies or nucleic acid test
• Active hepatitis B infection as documented by positive hepatitis B polymerase chain reaction (PCR) assay
• Use of investigational drug, other than the study medications specified by the protocol, within 30 days of transplantation
• Receipt of a live vaccine within 30 days of receipt of study therapy
• > grade II acute graft versus host disease (aGVHD)
• The presence of any medical condition that the Investigator deems incompatible with participation in the trial
• Subjects who are required to use a medication classified as a strong CYP3A inducer of inhibitor; an exception can be made for those patients required to take azole based antifungal prophylaxis and/or treatment