Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
Summary
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.
Timeline
- Start
- 2006-03
- Primary completion
- 2012-06
- Completion
- 2015-08
Outcome
Mixed primary results
registry NUMBER Arm II - Lenalidomide: 53.3 (37.9 to 68.3) percentage of participants NCT00238238 ↗
registry NUMBER Arm III - Lenalidomide and Rituximab: 76.1 (61.2 to 87.4) percentage of participants NCT00238238 ↗
registry Arm II - Lenalidomide vs Arm III - Lenalidomide and Rituximab; p = 0.29; Fisher Exact NCT00238238 ↗
registry MEDIAN Arm II - Lenalidomide: 1.1 (0.8 to 1.2) years NCT00238238 ↗
registry MEDIAN Arm III - Lenalidomide and Rituximab: 2 (1.7 to 3.0) years NCT00238238 ↗
registry Arm II - Lenalidomide vs Arm III - Lenalidomide and Rituximab; p = 0.002; Log Rank NCT00238238 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 20 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |