National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Simon Rule, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Derriford Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000269136
NCT ID:
NCT00053092
Start Date:
October 2002
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Mantle-Cell
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