A Phase II Trial of the Combination of Lenalidomide and Rituximab in Patients With Relapsed/Refractory Follicular NHL (RV 0163)
- To determine the response rate in patients with relapsed or refractory follicular or
small lymphocytic non-Hodgkin lymphoma treated with lenalidomide and rituximab.
- To determine the time to disease progression, duration of response, and overall
survival of these patients.
- To determine the tolerability of this regimen in these patients.
- To assess changes in serum cytokines before and after treatment and correlate these
changes with response.
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity. Patients also receive rituximab
IV on days 15 and 22 of course 1 and on days 1 and 8 of course 2. Patients who do not
achieve complete response after 2 courses of rituximab may receive up to 4 additional doses
of rituximab once weekly for 4 weeks.
Blood samples are collected at baseline and after treatment for cytokine analysis.
After completion of study treatment, patients are followed at 30 days and then every 3
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months
Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease.
Joseph M. Tuscano, MD
University of California, Davis
United States: Institutional Review Board
|University of California Davis Cancer Center||Sacramento, California 95817|