Mantle cell lymphoma (MCL) is an aggressive non-Hodgkin lymphoma (NHL) characterized by a short remission duration to standard therapies, poor prognosis, and median overall survival of 4-5 years. The immunomodulatory agent lenalidomide has consistently exhibited a tolerable level of safety in multiple phase II studies of relapsed/refractory aggressive NHL and MCL post-bortezomib. At the recent 2013 annual meeting of the American Society of Clinical Oncology, Dr. Thomas E. Witzig of the Mayo Clinic presented results from a combined analysis of multiple phase II trials testing the efficacy and safety of single-agent lenalidomide in relapsed/refractory MCL patients.
Of the 206 patients with relapsed/refractory MCL the overall response rate with lenalidomide was 32%, with a median time to response of 2.1 months and median duration of response of 16.6 months. Kaplan-Meier estimates for median progression free survival and overall survival were 5.4 and 23.9 months, respectively. Mean daily dose of lenalidomide was 21 mg. Grade 3/4 adverse events included neutropenia (44%), thrombocytopenia (29%), anemia (11%), and fatigue (7%), other side effects included tumor flare reaction (7%), venous thromboembolic events (7%), and invasive second primary malignancies (3%).
This study adds to the growing body of literature supporting the promise of lenalidomide for treating patients with MCL. At the Weill Cornell Lymphoma Program these breakthroughs are augmented by our own trials exploring the utility of lenalidomide in treating patients with MCL.
Update: this study is closed to enrollment.
The Weill Cornell Lymphoma Program is now enrolling patients in a new, investigator-initiated phase II study of lenalidomide in combination with rituximab in patients with previously untreated MCL (NCT01472562). The purpose of the study is to test the synergy of combining lenalidomide, a biological agent that targets the tumor micro-environment, with rituximab, an antibody that targets lymphoma cells. By including a maintenance phase of lenalidomide and rituximab therapy, we hope to improve treatment effectiveness and maintain quality of life for patients.
This is an outpatient treatment strategy because lenalidomide, the study medication, can be taken at home. After the first month on study, patients will be seen in clinic on average once a month. The study has two phases:
Induction Phase, Weeks 1-48:
- Treatment dose lenalidomide taken by mouth on days 1-21 of a 28-day cycle for 12 cycles
- Rituximab infusion for a total of 9 doses
Maintenance Phase, Week 49 until disease progression or for a maximum of 5 years from study entry:
- Maintenance dose lenalidominde taken by mouth on days 1-21 of a 28-day cycle
- Rituximab infusion one dose every 8 weeks