Treatment of Advanced Chronic Lymphocytic Leukemia (CLL) Fludarabine, Mitoxantrone and Cyclophosphamide With or Without G-CSF
- Compare the rate of remission, severe infections, and side effects in patients with
relapsed advanced chronic lymphocytic leukemia treated with fludarabine, mitoxantrone
hydrochloride, and cyclophosphamide with vs without filgrastim.
- Compare the overall survival, progression-free survival, and quality of remission in
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
- Arm I: Patients receive fludarabine IV on days 1-3, mitoxantrone hydrochloride IV on
day 1, and cyclophosphamide IV on days 1-3.
- Arm II: Patients receive fludarabine, mitoxantrone hydrochloride, and cyclophosphamide
as in arm I and filgrastim (G-CSF) beginning on day 6 and continuing until blood counts
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 165 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