search
Back to results

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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Zavedos
Cerubidine
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia in first complete remission

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Idarubicine

Daunorubicine

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 17, 2009
Last Updated
November 17, 2009
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01015196
Brief Title
Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation
Acronym
AML2001
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myeloid leukemia in first complete remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
832 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Idarubicine
Arm Type
Active Comparator
Arm Title
Daunorubicine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zavedos
Intervention Type
Drug
Intervention Name(s)
Cerubidine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23975179
Citation
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.
Results Reference
derived
PubMed Identifier
22911473
Citation
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.
Results Reference
derived
PubMed Identifier
22323482
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs