Status:
COMPLETED
Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Sanofi
Conditions:
Leukemia, Lymphocytic, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00464633
Start Date
March 1 2007
End Date
December 1 2011
Last Update
February 12 2013
Active Locations (34)
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1
Sanofi-Aventis Investigational Site Number 840008
San Diego, California, United States, 92103
2
Sanofi-Aventis Investigational Site Number 840022
San Francisco, California, United States, 94143
3
Sanofi-Aventis Investigational Site Number 840010
Chicago, Illinois, United States, 60611
4
Sanofi-Aventis Investigational Site Number 840012
Chicago, Illinois, United States, 60637