Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Treatment of Advanced Chronic Lymphocytic Leukemia (CLL) Fludarabine, Mitoxantrone and Cyclophosphamide With or Without G-CSF
RATIONALE: Drugs used in chemotherapy, such as fludarabine, mitoxantrone, and
cyclophosphamide, work in different ways to stop the growth of cancer cells, either by
killing the cells or by stopping them from dividing. Giving more than one drug (combination
chemotherapy) may kill more cancer cells. Colony stimulating factors, such as G-CSF, may
increase the number of immune cells found in bone marrow or peripheral blood and may help
the immune system recover from the side effects of combination chemotherapy. It is not yet
known whether giving combination chemotherapy alone is more effective than combination
chemotherapy together with G-CSF in treating patients with chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy
together with G-CSF to see how well it works compared to giving combination chemotherapy
alone in treating patients with relapsed stage I, stage II, stage III, or stage IV chronic
lymphocytic leukemia.
OBJECTIVES:
Primary
- 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.
Secondary
- Compare the overall survival, progression-free survival, and quality of remission in
these patients.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive fludarabine IV on days 1-3, 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
recover.
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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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