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

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ClinicalTrials.gov Identifier: NCT01015196
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : November 18, 2009
Information provided by:
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Zavedos Drug: Cerubidine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 832 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2001

Arm Intervention/treatment
Active Comparator: Idarubicine Drug: Zavedos
Experimental: Daunorubicine Drug: Cerubidine

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015196

Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cellule de promotion de la recherche clinique, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01015196     History of Changes
Other Study ID Numbers: BRD 99/10-L
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: November 18, 2009
Last Verified: November 2009

Keywords provided by Nantes University Hospital:
acute myeloid leukemia in first complete remission

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action