Acute Myeloid Leukemia
Conditions
Keywords
acute myeloid leukemia in first complete remission
Brief summary
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.
Interventions
DRUGCerubidine
DRUGZavedos
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 15 to 60 years * Diagnosis untreated AML (FAB 0 to 2, 4 to 7): more than 20% marrow blasts according to WHO classification * Signed informed consent required
Exclusion criteria
* AML3 subtype * Previous diagnosis of myelodysplastic syndrome (MDS) or myeloproliferative disease; patients with previous chemotherapy or radiotherapy were eligible if they had no previous diagnosis of MDS * Isolated extramedullary disease * Inadequate performance status (≥ 3), cardiac function (LVEF \< 40%, severe arythmia or unstable coronary disease), renal function (creatininine \> 150 µmol/l), liver functional tests (bilirubin \> 35 µmol/l, liver enzymes \> 4 times normal values); life expectancy \< 3 months * Informed consent refusal
Countries
France
Outcome results
None listed