NCT01015196

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
832

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

First QC Date

November 17, 2009

Last Update Submit

November 17, 2009

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemia in first complete remission

Study Arms (2)

Idarubicine

ACTIVE COMPARATOR
Drug: Zavedos

Daunorubicine

EXPERIMENTAL
Drug: Cerubidine

Interventions

ZavedosDRUG
Idarubicine
CerubidineDRUG
Daunorubicine

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (3)

  • Bertoli S, Bories P, Bene MC, Daliphard S, Lioure B, Pigneux A, Vey N, Delaunay J, Leymarie V, Luquet I, Blanchet O, Cornillet-Lefebvre P, Hunault M, Bouscary D, Fegueux N, Guardiola P, Dreyfus F, Harousseau JL, Cahn JY, Ifrah N, Recher C; Groupe Ouest-Est d'Etude des Leucemies Aigues et Autres Maladies du Sang (GOELAMS). Prognostic impact of day 15 blast clearance in risk-adapted remission induction chemotherapy for younger patients with acute myeloid leukemia: long-term results of the multicenter prospective LAM-2001 trial by the GOELAMS study group. Haematologica. 2014 Jan;99(1):46-53. doi: 10.3324/haematol.2013.091819. Epub 2013 Aug 23.

    PMID: 23975179DERIVED

  • Guieze R, Cornillet-Lefebvre P, Lioure B, Blanchet O, Pigneux A, Recher C, Bonmati C, Fegueux N, Bulabois CE, Bouscary D, Vey N, Delain M, Turlure P, Himberlin C, Harousseau JL, Dreyfus F, Bene MC, Ifrah N, Chevallier P; GOELAMS. Role of autologous hematopoietic stem cell transplantation according to the NPM1/FLT3-ITD molecular status for cytogenetically normal AML patients: a GOELAMS study. Am J Hematol. 2012 Dec;87(12):1052-6. doi: 10.1002/ajh.23311. Epub 2012 Aug 22.

    PMID: 22911473DERIVED

  • Lioure B, Bene MC, Pigneux A, Huynh A, Chevallier P, Fegueux N, Blaise D, Witz B, Delain M, Cornillon J, Luquet I, Blanchet O, Cornillet-Lefebvre P, Carre M, Hunault M, Larosa F, Lamy T, Randriamalala E, Ojeda-Uribe M, Berthou C, Fornecker L, Harousseau JL, Bouscary D, Ifrah N, Cahn JY; GOELAMS. Early matched sibling hematopoietic cell transplantation for adult AML in first remission using an age-adapted strategy: long-term results of a prospective GOELAMS study. Blood. 2012 Mar 22;119(12):2943-8. doi: 10.1182/blood-2011-05-352989. Epub 2012 Feb 9.

    PMID: 22323482DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

IdarubicinDaunorubicin

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

January 1, 2001

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

FR(1)