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Feasibility of Lenalidomide Therapy for Persistent Chronic Lymphocytic Leukemia after Allogeneic Transplantation
Maria R Khouri1, Elias J Jabbour1, Alison M Gulbis2
1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Insights
Lenalidomide treatment for persistent chronic lymphocytic leukemia (CLL) after stem cell transplant showed high toxicity and did not improve outcomes. Alternative therapies are needed for post-transplant CLL management.
Area of Science:
- Hematology
- Oncology
- Immunology
Background:
- Persistent chronic lymphocytic leukemia (CLL) post-allogeneic stem cell transplantation (alloSCT) is associated with poor prognosis.
- Graft-versus-host-disease (GVHD) is a significant complication following alloSCT.
Purpose of the Study:
- To evaluate the efficacy and safety of lenalidomide in patients with persistent CLL after alloSCT.
- To compare lenalidomide therapy with standard care (immunosuppression withdrawal and donor lymphocyte infusion) for persistent CLL.
Main Methods:
- Randomized trial of patients with persistent CLL 90-100 days post-alloSCT without GVHD.
- Lenalidomide initiated at 5 mg/day, escalated to 10 mg/day if tolerated, versus standard care.
- Median follow-up of 2.6 years.
Main Results:
- Only 17 of 38 enrolled patients met eligibility criteria; 8 were randomized to lenalidomide.
- Lenalidomide was discontinued due to toxicity in 62% of patients, primarily acute GVHD (43% vs. 11% in control).
- Median survival was 3.4 years for lenalidomide recipients; not reached in the control group or non-randomized complete remission patients.
Conclusions:
- Lenalidomide therapy for persistent CLL after alloSCT is associated with high toxicity, particularly acute GVHD.
- Lenalidomide did not demonstrate improved survival outcomes in this patient population.
- Novel therapeutic strategies are required for managing persistent CLL post-alloSCT.
Abstract:
In patients with chronic lymphocytic leukemia (CLL), persistence of disease after allogeneic stem cell transplantation (alloSCT) can result in poor outcomes. In an effort to improve these outcomes, patients with persistent CLL who were 90 to 100 days beyond alloSCT with no evidence of graft-versus-host-disease (GVHD) were randomized to receive lenalidomide or standard care (withdrawal of immunosuppression followed by donor lymphocyte infusion). Lenalidomide was initiated at 5 mg every other day and increased to 10 mg daily, if tolerated, in each patient. Of 38 patients enrolled, 17 (45%) met the eligibility criteria for randomization. Of these 17 patients, 8 were randomized to undergo lenalidomide therapy. Five (62%) patients had to stop taking the drug because of toxicity. The main reason for drug discontinuation was acute GVHD in 43% of patients. This incidence was 11% in the patients who were randomized to not receive lenalidomide. With a median follow-up of 2.6 years, the median survival was 3.4 years for those receiving lenalidomide. This was not reached in patients randomized to not receive lenalidomide and in patients in complete remission who were not randomized. These results suggested that treatments other than lenalidomide are needed for persistent CLL after alloSCT.
