Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: rituximab
* Drug: cyclophosphamide
* Drug: fludarabine phosphate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed previously untreated mantle cell lymphoma requiring therapy Any stage PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy At least 3 months Hematopoietic Not specified Hepatic Bilirubin no greater than 2.5 times upper limit of normal (ULN)^* Alkaline phosphatase no greater than 2.5 times ULN^* Hepatitis B and hepatitis C negative NOTE: *Unless related to lymphoma Renal Creatinine no greater than 2.5 times ULN^* NOTE: *Unless related to lymphoma Other No other malignancy within the past 5 years except non-melanoma skin cancer or curatively resected carcinoma in situ of the cervix No prior psychological illness or condition that would preclude study compliance No known hypersensitivity to murine proteins No concurrent uncontrolled medical conditions No other illness that would severely limit life expectancy HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rituximab|nan|
|Drug: cyclophosphamide|nan|
|Drug: fludarabine phosphate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Time to disease progression |  |  | 
| Toxicity |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma