A Phase I-II Study of the Efficacy and Safety of Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes
Patients will receive ldarubicin combined to Azacytidine.
- The first 10 patients will receive Idarubicin 5 mg/m2/d on day 8 of each cycle of
Azacytidine 75 mg/m2/d CI during 7 days (First Cohort ).
- Progression or not to the next cohort of 10 patients : Idarubicin 10 mgm2/d on day 8 of
each cycle of Azacytidine 75 mg/m2/d CI during 7 days (Second cohort of 10 patients),
will be decided after completion of the first cohort, after review of hematological
toxicity by an independent safety review committee (SRC).
- The next 21 patients will be treated either accoding to the first or second cohort
schedule of idarubicin, after review of hematological toxicity and efficacy by an
independent safety review committee (SRC).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determined tolerance and dose limiting toxicities to idarubicine and azacitidine association.
After 12 weeks treatment
Lionel ADES, PHD,MD
GFM: Groupe Francophone des Myélodysplasies
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)