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.

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.