Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00053092|
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : December 18, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate||Phase 2|
- Compare the response rates in patients with previously untreated mantle cell lymphoma treated with fludarabine and cyclophosphamide with or without rituximab.
- Compare the time to disease progression in patients treated with these regimens.
- Compare the toxicity of these regimens, in terms of adverse event profile, in these patients.
- Compare the overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive fludarabine IV* and cyclophosphamide IV* on days 1-3.
- Arm II: Patients receive rituximab IV on day 1 and fludarabine IV* and cyclophosphamide IV* on days 2-4.
NOTE: *In both arms, fludarabine and cyclophosphamide may be administered orally instead of IV.
Treatment repeats every 28 days for 2-8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 56-82 patients (28-41 per treatment arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Masking:||None (Open Label)|
|Official Title:||National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||February 2009|
- Response rate
- Time to disease progression
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053092
|Peter MacCallum Cancer Centre|
|East Melbourne, Victoria, Australia, 3002|
|Plymouth, England, United Kingdom, PL6 8DH|
|Study Chair:||Simon Rule, MD||Derriford Hospital|
|Study Chair:||John Seymour, MD||Peter MacCallum Cancer Centre, Australia|