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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Alvocidib

Criteria

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.