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

Sponsor

Institute of Cancer Research, United Kingdom (Other)

Overall Status

Completed

CT.gov ID

NCT00053092

Collaborator

Australasian Leukaemia and Lymphoma Group (Other)

Enrollment

Locations

76.1

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Oct 1, 2002

Actual Study Completion Date :

Feb 1, 2009

Outcome Measures

Primary Outcome Measures

Response rate []
Time to disease progression []
Toxicity []
Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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