Acute Myeloid Leukemia Clinical Trial
Official title:
AML 2001: a Phase III Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation (ASCT) as Consolidation Strategy for Adults Aged 15 to 60 With Acute Myeloid Leukemia (AML) in First Complete Remission (CR).rémission complète d'Une Leucémie Aiguë Myéloblastique
First randomization:
After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all
courses of chemotherapy (induction, consolidation courses before ASCT)
Second randomization:
After achieving 1st CR: all patients received non intensive consolidation course Familial
HLA typing required for all patients
Patients with HLA-identical sibling:
Patients with very good prognostic factors (CBF leukemias, WBC < 30 giga/l at diagnosis, 1st
CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR;
received 2 more courses of intensive consolidation chemotherapy All others patients received
an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative
conditioning regimen For patients aged over 51 and less than 61= arm m: intensive
chemotherapy consolidation course.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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