Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers

• Status: Completed
• Trial end date: 2012-11-09
• Target enrollment: 0
• Participant gender: All

Summary

This phase I clinical trial is studying the side effects and the best dose of lenalidomide after donor bone marrow transplant in treating patients with high-risk hematologic cancer. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Histologically confirmed hematologic malignancy meeting 1 of the following criteria:

• High-risk acute myeloid leukemia meeting 1 the following criteria:

• First complete response (CR) and ≥ 60 years of age OR < 60 years of age with high-risk cytogenetics as defined by CALGB OR high-molecular risk and not eligible or willing to undergo myeloablative conditioning

• Second or later complete remission

• Not in remission but with < 5% blasts within 3 weeks of start of conditioning chemotherapy for allogeneic transplantation

• Patients with a history of CNS involvement allowed provided disease is in remission at the time of transplantation

• Patients with non-Hodgkin lymphoma who are candidates for allogeneic stem cell transplantation will be eligible; patients who have relapsed status post autologous transplantation are eligible as long as they demonstrate chemotherapy sensitive disease; patients with a history of CNS involvement are eligible if this aspect of the disease is in remission at the time of transplantation

• High-risk chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or primary and secondary B-prolymphocytic leukemia (PLL) meeting 1 of the following criteria:

• del(17p13.1) disease that has been treated (may have been given as consolidation therapy)

• Less than PR to chemoimmunotherapy or relapsed within 2 years of treatment

• Nucleoside analog refractory disease or disease that relapsed after two prior regimens

• Patients with Richter (large cell) transformation allowed provided the large cell component of the disease is in remission (< 10% large cells in the bone marrow allowed)

• Patient has undergone an allogeneic stem cell transplantation using a reduced-intensity or non-myeloablative conditioning regimen within the past 60 days

• At least 40% T-cell donor chimerism at day 30

• ECOG performance status 0-2 (Karnofsky 60-100%)

• Life expectancy > 3 months

• Myeloid engraftment with absolute neutrophil count > 1,000/μL and platelet count > 50,000/μL (after allogeneic hematopoietic stem cell transplantation [AHSCT])

• Total bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• AST < 3 times ULN after AHSCT

• Creatinine clearance ≥ 50 mL/min in stratum 1 or ≥ 30 mL/min in stratum 2

• DLCO > 40% with no symptomatic pulmonary disease

• LVEF ≥ 30% by echocardiogram or MUGA

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must agree to use two acceptable methods of contraception (one highly effective method and one additional effective method) or practice abstinence for ≥ 28 days before, during, and ≥ 28 days after completing lenalidomide

• HIV negative

• No uncontrolled infection requiring intravenous therapy or poorly controlled diabetes mellitus

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness and/or social situations that would limit compliance with study requirements

• No history of grade 3 or 4 graft-vs-host disease (GVHD)

• If patient has acute GVHD grade 1 or 2, GVHD must be controlled and dose of oral prednisone or equivalent ≤ 20 mg per day (after AHSCT)

• More than 4 weeks since prior chemotherapy (excluding steroids), radiotherapy, or radioimmunoconjugate therapy (6 weeks for nitrosoureas or mitomycin C) and recovered

• No other concurrent investigational agents