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

This is an interventional treatment trial for Adult Acute Myeloid Leukemia in Remission Read More

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