NCT00003620

Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• B-cell Chronic Lymphocytic Leukemia
• Refractory Chronic Lymphocytic Leukemia
• Stage I Chronic Lymphocytic Leukemia
• Stage II Chronic Lymphocytic Leukemia
• Stage III Chronic Lymphocytic Leukemia
• Stage IV Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	alvocidib	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 1999-06-01
• Primary completion: 2006-06-01
• First posted: 2003-09-25
• Last updated: 2013-01-17

Locations

1 site across 1 country: United States