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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
165
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.
Best overall objective response rate
Objective Response Rate (ORR) is defined as the proportion of participants with complete response or partial response (including nodular partial response) relative to the total number of participants. Response assessment is based on evaluation of nodal disease by Computerized Tomography (CT) and National Cancer Institute Working Group 96 criteria (NCI-96) for assessment of liver, spleen, constitutional symptoms, peripheral blood (±) bone marrow.
Time frame: Up to a maximum of 6 cycles
Progression-free survival
Progression-free survival (PFS) is defined as the time from the date of first administration of study drug to the first documentation of progressive disease or death due to any cause in the absence of previous documentation of objective progression.
Time frame: Up to a maximum of 6 cycles
Duration of objective response
Duration of objective response is defined from the time of first occurrence of complete response or partial response (including nodular partial response) to the first documentation of progressive disease or death due to any cause in the absence of previous documentation of objective progression.
Time frame: Up to a maximum of 6 cycles
Overall survival
Overall survival (OS) is defined as the time from the date of first administration of study drug to death.
Time frame: Up to a maximum of 6 cycles
Overview of adverse events
Time frame: from study drug administration up to 30 days after last study drug administration
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Sanofi-Aventis Investigational Site Number 840008
San Diego, California, United States
Sanofi-Aventis Investigational Site Number 840022
San Francisco, California, United States
Sanofi-Aventis Investigational Site Number 840010
Chicago, Illinois, United States
Sanofi-Aventis Investigational Site Number 840012
Chicago, Illinois, United States
Sanofi-Aventis Investigational Site Number 840017
Indianapolis, Indiana, United States
Sanofi-Aventis Investigational Site Number 840001
Boston, Massachusetts, United States
Sanofi-Aventis Investigational Site Number 840023
Ann Arbor, Michigan, United States
Sanofi-Aventis Investigational Site Number 840005
New York, New York, United States
Sanofi-Aventis Investigational Site Number 840006
New York, New York, United States
Sanofi-Aventis Investigational Site Number 840003
Durham, North Carolina, United States
...and 24 more locations