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

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01015196
Collaborator
(none)
832
Enrollment
1
Location
2
Arms

Study Details

Study Description

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
Phase 2/Phase 3

Study Design

Study Type:
Interventional
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 :
Jan 1, 2001

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Idarubicine

Drug: Zavedos
Experimental: Daunorubicine

Drug: Cerubidine

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 60 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nantes University Hospital Nantes France 44093

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01015196
    Other Study ID Numbers:
    • BRD 99/10-L
    First Posted:
    Nov 18, 2009
    Last Update Posted:
    Nov 18, 2009
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    acute myeloid leukemia in first complete remission
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Daunorubicin

    Study Results

    No Results Posted as of Nov 18, 2009