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Phase I-II trial to assess the dose limiting toxicity, tolerance and efficacy of hemi-synthetic homoharringtonine (Myelostat®) in combination with imatinib mesylate (Glivec®) in patients with chronic myeloid leukemia after cytogenetic failure with Glivec®
  Sponsor : Stragen France
  Investigator Coordinator : Prof F. Guilhot CHU Poitiers France
 
Studie Objective
 

Determination of the maximum tolerated dose of Myelostat® in association with Glivec®.

 
 
  Selected Inclusion criteria  
  1. Patients aged between 18 and 70 years

2. Chronic myeloid leukemia (CML) Philadelphia positive detected by cytogenetics or FISH, in the 1st chronic phase and in complete hematologic remission.

3. Cytogenetic failure:
• either by the absence of a major cytogenetic response after at least one year of treatment with imatinib mesylate at a dose of 400 mg/day at least.
• or by the persistence of 100% Ph+ mitoses after at least 6 months of treatment with imatinib mesylate administered at a dose of 400 mg/day at least.

4. Treatment with Glivec 400 mg/day, well-tolerated and without interruption in the previous month

  
 
  Selected Exclusion criteria  
 

1. Previous treatment with homoharringtonine

2. Intolerance to Glivec®

3. Patient scheduled for hematopoietic stem cell allograft

  
 
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