Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma
RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. 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. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab, cyclophosphamide, and dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab, cyclophosphamide, and dexamethasone works in treating patients with previously untreated low-grade non-Hodgkin lymphoma.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone (LR-CD) for Untreated Low Grade Non-Hodgkin Lymphoma Requiring Therapy|
- Proportion of confirmed complete responses [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Progression-free survival time [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
- To assess tumor response to lenalidomide, rituximab, cyclophosphamide, and dexamethasone in patients with symptomatic previously untreated low-grade non-Hodgkin lymphoma.
- To describe the adverse event profile of this regimen.
- To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure associated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21, rituximab IV on day 1, oral cyclophosphamide once daily on days 1, 8, and 15, and oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784927
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Craig B Reeder, MD||Mayo Clinic|
|Principal Investigator:||Thomas E. Witzig, MD||Mayo Clinic|