Leukemia Clinical Trial
Official title:
Randomized Phase-III Trial Comparing Fludarabine and Cyclophosphamide Plus Rituximab (FCR) to FC and MabCampath (FCCam) for Previously Untreated Fit Patients With Chronic Lymphocytic Leukemia (CLL)
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in
different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such
as rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer
cells and help kill them or carry cancer-killing substances to them. Others interfere with
the ability of cancer cells to grow and spread. It is not yet known whether giving
fludarabine and cyclophosphamide together with rituximab is more effective than giving
fludarabine and cyclophosphamide together with alemtuzumab in treating B-cell chronic
lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying giving fludarabine together with
cyclophosphamide and rituximab to see how well it works as first-line therapy compared with
giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with
B-cell chronic lymphocytic leukemia.
OBJECTIVES:
Primary
- To compare 36-month progression-free survival in patients with Binet stage B or C
B-cell chronic lymphocytic leukemia treated with first-line therapy comprising
fludarabine phosphate and cyclophosphamide and either rituximab or alemtuzumab.
Secondary
- To compare the disease-free survival, event-free survival, and overall survival of
patients treated with these regimens.
- To compare time to next treatment in patients treated with these regimens.
- To compare the overall response rate (complete response [CR] and partial response [PR])
in patients treated with these regimens.
- To compare the rate of phenotypic and molecular response in patients treated with these
regimens.
- To compare the duration of phenotypic, molecular, complete and partial responses in
patients treated with these regimens.
- To compare the response rates and survival times in biological subgroups.
- To compare the rates of treatment-related adverse effects in patients treated with
these regimens.
- To compare the quality of life of patients treated with these regimens.
- Minimal residual disease study.
OUTLINE: This is a multicenter study. Patients are stratified according to Ig mutational
status and cytogenetic abnormalities. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive rituximab IV on day 1 and fludarabine phosphate and
cyclophosphamide IV or orally on days 2-4 of course 1. Beginning in course 2 and for
all subsequent courses, patients receive rituximab IV on day 1 and fludarabine
phosphate and cyclophosphamide IV or orally on days 1-3.
- Arm II: Patients receive alemtuzumab subcutaneously, oral fludarabine phosphate, and
oral cyclophosphamide on days 1-3.
In both arms, treatment repeats every 28 days for 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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