Leukemia, Lymphocytic, Chronic Clinical Trial
Official title:
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
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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