Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
- 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.
- Compare the incidence of side effects and quality of life of patients treated with
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Michael Hallek, MD
Medizinische Universitaetsklinik I at the University of Cologne
United States: Federal Government