Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : lenalidomide
Phase: Phase 2
Ages Eligible For Study:
- Relapsed or refractory acute lymphoblastic leukemia (ALL) with > 10% bone marrow or peripheral blood blasts per WHO-criteria. Refractory define as failure to achieve CR after prior therapy. - Previously untreated patients > 60, if not candidates for standard induction - Age ? 18 - Not a candidate for curative treatment regimens - Unwilling or unable to receive conventional chemotherapy - ECOG performance status ? 2 - Life expectancy > 2 months - Registered to in RevAssist restricted distribution program, and willing and able to comply with the program requirement - Females of childbearing potential (FCBP): - Must have a negative serum or urine pregnancy test (sensitivity of at least 50 mIU/mL) 10 to 14 days prior to study enrollment and within 24 hours prior to prescribing lenalidomide - Must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - Agree to ongoing pregnancy testing - Men must agree to use a latex condom during sexual contact with a FCBP - Able to adhere to the study visit schedule and other protocol requirements - Willing and able to understand and voluntarily sign a written informed consent