drugset / Trial / NCT00464633

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

NCT00464633

Phase 2 Completed 165 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-03
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject alvocidib Small molecule 30 mg/m2 Intravenous
Subject alvocidib Small molecule 50 mg/m2 Intravenous