Refractory Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA
Phase II trial to study the effectiveness of flavopiridol in treating patients who have chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
OBJECTIVES: Determine the complete and partial response rate to flavopiridol in patients
with fludarabine-refractory chronic lymphocytic leukemia.
Assess the toxicity profile of this treatment in these patients. Examine progression-free
survival and overall survival following this treatment in these patients.
Determine the effects of flavopiridol on normal T-cell subsets and immunoglobulin levels in
these patients.
OUTLINE: This is an open label, multicenter study.
Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3.
Treatment repeats every 14 days for a total of 12 courses in the absence of disease
progression or unacceptable toxicity.
Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3.
Treatment repeats every 3 weeks for a total of 8 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for the first year and then every 6 months for 5 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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