This phase 3 clinical trial will test the effectiveness of a lenalidomide (Revlimid) and rituximab(Rituxan) maintenance therapy followed by rituximab and lenalidomide or rituximabonly in treating relapsed follicular, marginal zone, or mantle cell lymphoma. The primary outcome will be measured by the time to disease progression.
Follicular, marginal zone, and mantle cell lymphoma are cancers of the B-cell. Maintenance therapies are usually needed after initial treatment to either slow the growth or prevent the return of the cancer. Lenalidomide inhibits (blocks) the production of tumor secreted signaling molecules, the formation of new blood vessels around the tumor, and cancer cell growth and division. Rituximab is an immunotherapy that uses the body’s own immune system to identify and kill cancerous B-cells. It is an antibody (a protein in the immune system) that binds to a protein found on B-cells, which alerts other parts of the immune system to attack.
This study will examine the time to disease progression, response rate, and adverse (negative) events for up to 8 years.
Who are they looking for?
This trial is recruiting 500 patients with relapsed follicular (stage 1, 2, or 3a), marginal zone, or mantle cell lymphoma who have relapsed or progressed after their last treatment. Patients must have adequate bone marrow function.
Ideal patients should not have received systemic cancer therapy within 28 days prior to treatment, antibody agents within 8 weeks, or radiotherapy 3 months prior to treatment. Participants should be off corticosteroids for at least 1 week before starting the trial. Patients cannot have hepatitis B or C, HIV, or central nervous system involvement with lymphoma.
How will it work
Patients will be divided into two groups, and the trial will be broken up into an induction and maintenance period. During the induction period, both groups will receive lenalidomide and rituximab.Lenalidomidewill be takenby mouth once a day on days 1-21 of a 28-day cycle for 12 cycles. Rituximab will be delivered intravenously (through IV into a vein) on day 1, 8, 15, and 22 then on day 1 of cycles 3, 5, 7, 9, and 11.
During the maintenance period, one group will continue treatment with lenalidomide alone, and the other will continue rituximabalone. The group that receives lenalidomide will administered the treatment during cycles 13-30. Rituximabtreatment will be given on alternating cycles 13-29.