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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Given IV
Correlative studies
Cancer and Leukemia Group B
Chicago, Illinois, United States
Complete + partial response rate
The CR + PR rate will be estimated with a 95% confidence interval, and the success of the study will be judged with the two-stage design given above.
Time frame: Up to 5 years
Toxicity profile of flavopiridol
Toxicities will be tabulated by type and grade
Time frame: Up to 5 years
Progression-free survival
Will be estimated using the Kaplan-Meier method.
Time frame: From onstudy date to the date of progression or death, assessed up to 5 years
Overall survival
Time frame: From onstudy date to the date of death, assessed up to 5 years
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