Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
Recruitment status was Recruiting
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory|
- Response rate (overall and complete) at 2, 4, 6, 9, 12, 15, 18, and 24 months, and then yearly for up to 10 years [ Designated as safety issue: No ]
- Time to progression for up to 10 years [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Estimated Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I (closed to accrual as of 9/15/07)
Patients receive rituximab IV on days 1, 8, 15, and 22.
Experimental: Arm II
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Experimental: Arm III
Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, and 22 of course 1 and day 1 of course 2 of lenalidomide.
Given IVDrug: lenalidomide
- Compare the overall and complete response rate in patients with follicular non-Hodgkin's lymphoma that has relapsed after treatment with rituximab and/or lenalidomide.
- Compare time to progression (TTP) in patients treated with these regimens.
- Compare TTP after prior rituximab-based combination therapy vs TTP in patients treated with these regimens.
- Determine the toxicity profile of these regimens in these patients.
- Correlate Fc-receptor-polymorphism profiling with response in patients treated with these regimens.
- Correlate changes in natural killer (NK) cells, activated NK cells, activated T-cells, and several plasma cytokines after exposure to lenalidomide therapy, followed by rituximab, with objective response rate in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I (closed to accrual as of 9/15/07): Patients receive rituximab IV on days 1, 8, 15, and 22.
- Arm II: Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, and 22 of course 1 and day 1 of course 2 of lenalidomide.
After completion of study treatment, patients are followed for up to 10 years from study entry.
PROJECTED ACCRUAL: A total of 180 patients (90 for arm I [closed to accrual as of 9/15/07], 45 each for arms II and III) will be accrued for this study.