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
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Up to a maximum of 6 cycles
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
EFC6663
NCT00464633
March 2007
December 2011
Name | Location |
---|---|
Sanofi-Aventis Investigational Site Number 840008 | San Diego, California 92103 |
Sanofi-Aventis Investigational Site Number 840022 | San Francisco, California 94143 |
Sanofi-Aventis Investigational Site Number 840010 | Chicago, Illinois 60611 |
Sanofi-Aventis Investigational Site Number 840012 | Chicago, Illinois 60637 |
Sanofi-Aventis Investigational Site Number 840017 | Indianapolis, Indiana 46202 |
Sanofi-Aventis Investigational Site Number 840001 | Boston, Massachusetts 02115 |
Sanofi-Aventis Investigational Site Number 840023 | Ann Arbor, Michigan 48109-0759 |
Sanofi-Aventis Investigational Site Number 840005 | New York, New York 10021 |
Sanofi-Aventis Investigational Site Number 840006 | New York, New York 10029-6574 |
Sanofi-Aventis Investigational Site Number 840003 | Durham, North Carolina 27710 |
Sanofi-Aventis Investigational Site Number 840018 | Cleveland, Ohio 44106 |
Sanofi-Aventis Investigational Site Number 840002 | Columbus, Ohio 43210 |
Sanofi-Aventis Investigational Site Number 840020 | Philadelphia, Pennsylvania 19104 |