Lymphoma
Conditions
Keywords
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
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.
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.
Interventions
DRUGcyclophosphamide
DRUGfludarabine phosphate
BIOLOGICALrituximab
Sponsors
Australasian Leukaemia and Lymphoma Group
Institute of Cancer Research, United Kingdom
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
| Time to disease progression | — |
| Toxicity | — |
| Overall survival | — |
Countries
Australia, United Kingdom
Outcome results
None listed