Lymphoma Clinical Trial
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
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. 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.
Outline:
This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
Please see the "Arms" section for a description of each treatment arm. The primary and
secondary objectives of the study are provided below.
Primary Objectives:
- To determine the response rate (overall and complete) after lenalidomide therapy and
rituximab + lenalidomide in follicular NHL patients who have relapsed.
- To determine time to progression after lenalidomide therapy and rituximab and
lenalidomide in follicular NHL patients who have relapsed.
Secondary Objectives:
- To compare the time to progression of the previous rituximab regimen to that obtained
subsequently to lenalidomide therapy and rituximab + lenalidomide.
- To determine the toxicity profile of lenalidomide therapy and of rituximab and
lenalidomide in follicular NHL patients who have received a previous rituximab regimen.
- To correlate Fc receptor polymorphism profiling with response to lenalidomide or
rituximab + lenalidomide in previously treated patients with follicular NHL who have
relapsed.
- To evaluate changes in Natural Killer (NK) cells, activated NK cells, activated T-cells
and several plasma cytokines followed by rituximab therapy and correlation of observed
changes to objective response rates.
After completion of study treatment, patients are followed for up to 10 years from study
entry.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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