A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy
A academic multicentre study whose aims are to study the benefits of a maintenance therapy
with 24 monthly courses af azacytidine in high-risk MDS patients, previously treated with
intensive chemotherapy with obtention of a partial or complete response and not eligible for
allogeneic transplantation
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Reponse duration and cumulative incidence of relapses
1-24 months
Yes
Claude GARDIN, MD
Principal Investigator
Groupe Francophone des Myelodysplasies
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GFM aza05
NCT00446303
July 2006
July 2010
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