Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation (AML2001)

N

Nantes University Hospital (NUH)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Cerubidine
Drug: Zavedos

Study type

Interventional

Funder types

Other

Identifiers

NCT01015196
BRD 99/10-L

Details and patient eligibility

About

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.

Enrollment

832 patients

Sex

All

Ages

15 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

832 participants in 2 patient groups

Idarubicine
Active Comparator group
Treatment:
Drug: Zavedos
Daunorubicine
Experimental group
Treatment:
Drug: Cerubidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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