A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Up to 5 years
No
John Byrd
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-02280
NCT00003620
June 1999
Name | Location |
---|---|
Cancer and Leukemia Group B | Chicago, Illinois 60606 |