Lenalidomide is a drug that alters the immune system and it may also be directly toxic to tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast cells in preparation for a bone transplant.
We hypothesize that lenalidomide in high doses can be used to decrease bone marrow blast count in patients with relapsed or refractory acute myeloid leukemia in preparation for an allogeneic stem cell transplant with acceptable toxicities that are no worse than current cytotoxic chemotherapeutic agents. The known dose-limiting toxicity at 75 mg was excessive fatigue in a previous phase I trial which in this study may be irrelevant as all study participants will have an in-patient status.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Oral capsule, daily, 50mg-100mg, one cycle (21 days)
University of California Comprehensive Cancer Center
Sacramento, California, United States
Maximum Tolerated Dose (measured by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0)
All patients who receive the study drug will be followed closely and evaluated for toxicity. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE
Time frame: One Cycle (21 days)
Rates of complete response (CR) and complete response without platelet recovery (CRi)
Patients will be assessed for the efficacy (CR or CRi) if they have received at least 7 continuous days of study drug.
Time frame: One Cycle (21 days)
Pharmacokinetics of high-dose lenalidomide cell activity.
Plasma concentrations of lenalidomide will be studied
Time frame: At 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dose on day 1, as well as before morning dosing on days 8, 15, and 21 during the clinical therapy
Define the effects of lenalidomide on T and Natural Killer (NK) cell activity.
Blood samples will be drawn and will be tested for NK cell and T cell activity.
Time frame: Baseline and at two weeks after therapy
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