Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)

Completed · Phase 2

Conditions studied: Leukemia, Lymphocytic, Chronic

In brief

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.

Key facts

Study ID

NCT00464633

Run by

Sanofi

People needed

165

Starts

2007-03-01

Expected to finish

2011-12-01

Last updated by the study team

2013-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• 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
• Sanofi-Aventis Investigational Site Number 840018 — Cleveland, Ohio, United States
• Sanofi-Aventis Investigational Site Number 840002 — Columbus, Ohio, United States
• Sanofi-Aventis Investigational Site Number 840020 — Philadelphia, Pennsylvania, United States
• Sanofi-Aventis Investigational Site Number 036001 — St Leonards, Australia
• Sanofi-Aventis Investigational Site Number 056006 — Bruges, Belgium
• Sanofi-Aventis Investigational Site Number 056001 — Brussels, Belgium
• Sanofi-Aventis Investigational Site Number 056004 — Ghent, Belgium
• Sanofi-Aventis Investigational Site Number 056003 — Leuven, Belgium
• Sanofi-Aventis Investigational Site Number 056002 — Yvoir, Belgium
• Sanofi-Aventis Investigational Site Number 250001 — Paris, France
• Sanofi-Aventis Investigational Site Number 250003 — Pierre-Bénite, France
• Sanofi-Aventis Investigational Site Number 250002 — Tours, France
• Sanofi-Aventis Investigational Site Number 276001 — Cologne, Germany
• Sanofi-Aventis Investigational Site Number 276004 — Kiel, Germany
• Sanofi-Aventis Investigational Site Number 276002 — Ulm, Germany

Full record on ClinicalTrials.gov

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