Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
- Registration Number
- NCT00464633
- Lead Sponsor
- Sanofi
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- Patient must have documentation of histologically confirmed and measurable Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL;
- Patient must have symptomatic and progressive disease;
- Patient must have received prior alkylating agent(s) and be fludarabine refractory;
- Patient must have the adequate organ functions;
- Patient's Eastern Cooperative Oncology Group performance (ECOG) status must be 0-2;
- Patient with de novo PLL;
- Patient with secondary malignancy that will limit survival ≤5 years;
- Patient with prior allogenic or autologous bone marrow transplant or peripheral blood stem cell transplant ≤12 months;
- Patient receiving an investigational agent or an approved agent for an investigational purpose within last 4 weeks prior to study entry;
- Patient with known history of glucose-6-phosphate dehydrogenase deficiency;
- Patient with autoimmune hemolytic anemia;
- Patient with known Central Nervous System involvement;
- Patient with active, uncontrolled serious bacterial, viral or fungal infections
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Alvocidib alvocidib Cycles with 4-week treatment with alvocidib followed by 2-week rest period for up to a maximum of 6 cycles
- Primary Outcome Measures
Name Time Method Best overall objective response rate 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.
- Secondary Outcome Measures
Name Time Method Progression-free survival 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 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 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 from study drug administration up to 30 days after last study drug administration
Trial Locations
- Locations (34)
Sanofi-Aventis Investigational Site Number 840023
🇺🇸Ann Arbor, Michigan, United States
Sanofi-Aventis Investigational Site Number 250002
🇫🇷Tours, France
Sanofi-Aventis Investigational Site Number 840017
🇺🇸Indianapolis, Indiana, United States
Sanofi-Aventis Investigational Site Number 276002
🇩🇪Ulm, Germany
Sanofi-Aventis Investigational Site Number 380002
🇮🇹Bologna, Italy
Sanofi-Aventis Investigational Site Number 380001
🇮🇹Milano, Italy
Sanofi-Aventis Investigational Site Number 528003
🇳🇱Amsterdam, Netherlands
Sanofi-Aventis Investigational Site Number 840010
🇺🇸Chicago, Illinois, United States
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 840012
🇺🇸Chicago, Illinois, United States
Sanofi-Aventis Investigational Site Number 840001
🇺🇸Boston, Massachusetts, 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 840018
🇺🇸Cleveland, Ohio, United States
Sanofi-Aventis Investigational Site Number 840020
🇺🇸Philadelphia, Pennsylvania, United States
Sanofi-Aventis Investigational Site Number 840003
🇺🇸Durham, North Carolina, United States
Sanofi-Aventis Investigational Site Number 036001
🇦🇺St Leonards, Australia
Sanofi-Aventis Investigational Site Number 840002
🇺🇸Columbus, Ohio, United States
Sanofi-Aventis Investigational Site Number 056004
🇧🇪Gent, Belgium
Sanofi-Aventis Investigational Site Number 056006
🇧🇪Brugge, Belgium
Sanofi-Aventis Investigational Site Number 056001
🇧🇪Bruxelles, Belgium
Sanofi-Aventis Investigational Site Number 056002
🇧🇪Yvoir, Belgium
Sanofi-Aventis Investigational Site Number 250001
🇫🇷Paris Cedex 13, France
Sanofi-Aventis Investigational Site Number 056003
🇧🇪Leuven, Belgium
Sanofi-Aventis Investigational Site Number 250003
🇫🇷Pierre Benite Cedex, France
Sanofi-Aventis Investigational Site Number 276004
🇩🇪Kiel, Germany
Sanofi-Aventis Investigational Site Number 276001
🇩🇪Köln, Germany
Sanofi-Aventis Investigational Site Number 528001
🇳🇱Groningen, Netherlands
Sanofi-Aventis Investigational Site Number 826005
🇬🇧Aberdeen, United Kingdom
Sanofi-Aventis Investigational Site Number 528002
🇳🇱Rotterdam, Netherlands
Sanofi-Aventis Investigational Site Number 826002
🇬🇧Birmingham, United Kingdom
Sanofi-Aventis Investigational Site Number 630001
🇵🇷San Juan, Puerto Rico
Sanofi-Aventis Investigational Site Number 826004
🇬🇧Bournemouth, United Kingdom