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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Collaborator: Australasian Leukaemia and Lymphoma Group
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab

Criteria

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