NCT00464633

Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)

A Multicenter, Open-label, Single Arm Study of Weekly Alvocidib in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising From CLL

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. Primary objective is to determine overall response rate. The secondary objectives are: * to assess overall safety, * to assess duration of response, progression free survival, and overall survival. Clinical benefit and pharmacokinetics parameters are also evaluated.

Detailed description

Treatment until disease progression or no evidence of treatment response; occurrence of unacceptable toxicity, intercurrent medical problem, or adverse event (AE); or a maximum of 6 cycles. Follow-up of 6 months after the last treatment with alvocidib. The maximum duration of the study participation for patient will be about 15 months.

Conditions

• Leukemia, Lymphocytic, Chronic

Interventions

Type	Name	Description
DRUG	alvocidib	1st dose: 30 mg/m2 as a 30-minute intravenous (IV) infusion followed by 30 mg/m2 as a 4-hour continuous infusion Then, every treatment week, depending upon the patient's objective response to initial therapy: * 30 mg/m2 over 30 minutes followed by 50 mg/m2 over 4 hours or * 30 mg/m2 over 30 minutes followed by 30 mg/m2 over 4 hours.

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2007-04-23
• Last updated: 2013-02-12

Locations

34 sites across 9 countries: United States, Australia, Belgium, France, Germany, Italy, Netherlands, Puerto Rico, United Kingdom