Status:
COMPLETED
Lenalidomide After Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancers
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 therapi...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximal-tolerable dose (MTD) of lenalidomide after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with advanced acute myeloid leukemia (AM...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01254578
Start Date
November 24 2010
End Date
November 9 2012
Last Update
September 25 2017
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210