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

This study has been completed.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01015196
First received: November 17, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 17, 2009
November 17, 2009
January 2001
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No Changes Posted
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Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: Zavedos
  • Drug: Cerubidine
  • Active Comparator: Idarubicine
    Intervention: Drug: Zavedos
  • Experimental: Daunorubicine
    Intervention: Drug: Cerubidine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
832
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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
Both
15 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01015196
BRD 99/10-L
No
Cellule de promotion de la recherche clinique, Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP