Clinical Trial: Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 (P
Brief 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 Summary:
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.
Sponsor: Sanofi
Current Primary Outcome: Best overall objective response rate [ Time Frame: Up to a maximum of 6 cycles ]
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.
Original Primary Outcome: Overall response rate using "hybrid" criteria (CT scan for assessment of nodal disease in combination with National Cancer Institute Working Group 96 criteria for assessment of liver/spleen, constitutional symptoms, peripheral blood +/- bone marrow).
Current Secondary Outcome:
- Progression-free survival [ Time Frame: Up to a maximum of 6 cycles ]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.
- Duration of objective response [ Time Frame: Up to a maximum of 6 cycles ]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.
- Overall survival [ Time Frame: Up to a maximum of 6 cycles ]Overall survival (OS) is defined as the time from the date of first administration of study drug to death.
- Overview of adverse events [ Time Frame: from study drug administration up to 30 days after last study drug administration ]
Original Secondary Outcome: Progression-free survival, overall survival, incidence of Adverse Events, clinical benefit assessment.
Information By: Sanofi
Dates:
Date Received: April 20, 2007
Date Started: March 2007
Date Completion:
Last Updated: February 8, 2013
Last Verified: February 2013
