Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
RATIONALE: 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with bortezomib and dexamethasone works in treating patients with relapsed or refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell lymphoma.
Other: questionnaire administration
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE®), and Dexamethasone (R-CyBor-D) in Relapsed Low Grade and Mantle Cell Lymphoma|
- Proportion of responses (complete response or partial response) [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
- To assess tumor response in patients with relapsed or refractory low-grade follicular lymphoma (grade I or II), mantle cell lymphoma, or lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia) treated with rituximab, cyclophosphamide, bortezomib, and dexamethasone.
- To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure in patients treated with this regimen.
- To describe the adverse event profile (as assessed by NCI CTCAE version 3.0) of this regimen in these patients.
- To evaluate the quality of life, in terms of patient-reported neurotoxicity, in patients treated with this regimen.
OUTLINE: Patients receive rituximab IV on day 1, bortezomib IV on days 1, 4, 8, and 11, and oral cyclophosphamide and oral dexamethasone 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.
Patients complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0) at baseline, on day 1 of courses 3, 6, and 9, and at the completion of study treatment.
After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711828
|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, M.D.||Mayo Clinic|
|Principal Investigator:||Thomas E. Witzig, M.D.||Mayo Clinic|