Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in
different ways to stop the growth of cancer cells, either by killing the cells or by stopping
them from dividing. It is not yet known whether giving fludarabine together with
cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic
leukemia.
PURPOSE: This randomized phase III trial is studying giving fludarabine together with
cyclophosphamide to see how well it works compared to fludarabine alone in treating patients
with advanced chronic lymphocytic leukemia.
OBJECTIVES:
Primary
- Compare the progression-free survival, as well the overall survival and duration of
remission in patients with previously untreated, advanced chronic lymphocytic leukemia
treated with fludarabine with versus without cyclophosphamide.
Secondary
- Compare the incidence of side effects and quality of life of patients treated with these
drugs.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment
arms
- Arm I: Patients receive fludarabine IV on days 1-5.
- Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both
arms, treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
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