|Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
This phase II clinical trial is studying how well giving lenalidomide and rituximab together works in treating patients with stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. 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. Giving lenalidomide together with rituximab may kill more cancer cells.
Further Study Information
I. To determine the response rate (overall and complete) to treatment with lenalidomide and rituximab in patients with follicular non-Hodgkin lymphoma (NHL) who have received no prior systemic therapy.
II. To determine the time to progression after treatment with lenalidomide and rituximab in patients with previously untreated CD20+ follicular NHL.
I. To determine the toxicity profile of this regimen in patients with previously untreated CD20+ follicular NHL.
II. To establish whether the therapeutic effects of this regimen are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).
III. To correlate Fcγ receptor polymorphism profiling with response to treatment with this regimen in patients with previously untreated follicular NHL.
IV. To determine the impact of lenalidomide on immune parameters in patients with previously untreated follicular NHL.
V. To determine the impact of lenalidomide on angiogenic parameters in patients with previously untreated follicular NHL.
VI. To correlate lymphoma-associated macrophages (LAM) and FOXP3, GzB, CD10, MUM1, and BCL2 expression with response to treatment with this regimen in patients with previously untreated follicular NHL.
VII. To determine whether immune gene signatures previously identified as prognostic factors in follicular lymphoma can be applied to paraffin-embedded tissues in patients treated with rituximab, to evaluate microRNA signatures associated with these gene signatures and outcome, to validate immunohistochemical markers associated with outcome in follicular lymphoma (CD68 LAMs, FOXP3, CD10, BCL6, FOXP1, MUM1), and to investigate whether markers of angiogenesis may be of value in the prognosis of follicular NHL.
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.
Blood, plasma, and tissue samples may be collected periodically for correlative studies.
After completion of study treatment, patients are followed up every 4 months for 2 years and then every 6 months for up to 8 years.
Trial Lead Organizations/Sponsors
National Cancer Institute
Link to the current ClinicalTrials.gov record.
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.