Randomised Prospective Comparison of the nonmyélo-Ablative Allograft and the Traditional Allograft in Acute Myeloid Leukaemia in Complete Remission of the Adult
Will not be included in CR1 nor the patients with good forecast under chemotherapy, (Inv 16;
t(8;21)), nor patients at the very high risk of relapse (anomalies complex cytogenetics).
The conditioning of MA graft will be Cyclophosphamide and ICT with strong amounts. NMA graft
will be made according to the protocol Seattle (fludarabine 30 mg/m2/j X 3 and ICT of 2 Gy).
The study will be undertaken in 12 French centers of allograft taking part in the protocols
ESPARTO or EORTC.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To show that NMA graft reduces mortality related to the procedure to 10%, compared to 30% waited in the arm of reference (α : 5%; p: 80%; bilateral formulation), 50 patients will be included in each arm
CORDONNIER Catherine, Professor
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)