NCT00927498

Brief Summary

The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_3

Geographic Reach
1 country

19 active sites

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

December 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

3.6 years

First QC Date

April 29, 2009

Last Update Submit

July 10, 2013

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid Leukemiapatient aged 50 to 70 years

Outcome Measures

Primary Outcomes (1)

  • Event Free Survival (EFS)

    Relapse or death measured from randomization

Secondary Outcomes (6)

  • CR rate

    CR after induction

  • Cumulative incidence of relapse

    Relapse from CR

  • Overall Survival

    Survival from randomization

  • Safety of the combination Mylotarg+chemotherapy

    Duration of study

  • Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM)

    Duration of study

  • +1 more secondary outcomes

Study Arms (2)

Arm A Daunorubicin and Cytarabine

ACTIVE COMPARATOR

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

Drug: conventional chemotherapy (AraC + Daunorubicin),

Arm B Daunorubicin and Cytarabine and Mylotarg

EXPERIMENTAL

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4. Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.

Drug: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),

Interventions

conventional chemotherapy (AraC + Daunorubicin),DRUG

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

Arm A Daunorubicin and Cytarabine
Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),DRUG

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2. Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4. Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.

Arm B Daunorubicin and Cytarabine and Mylotarg

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a morphologically proven diagnosis AML and both the two following criteria: Age \> 50 years and £ 70 years. Not previously treated for their disease.
  • ECOG performance status 0 to 3
  • Negative serology HIV, HBV and HBC (except post vaccination)
  • Serum creatinin inf 2.5N; AST and ALT inf 2.5N; total bilirubin inf 2N
  • Cardiac function determined by radionucleide or echography within normal limits.
  • Negative serum pregnancy test within one week before treatment for women of child bearing potential.
  • Signed informed consent.

You may not qualify if:

  • M3-AML
  • AML following previously know myeloproliferative syndrome.
  • Known central nervous system involvement.
  • Uncontrolled infection
  • Other active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

CH

Argenteuil, 95107, France

Location

Hopital Avicenne

Bobigny, 93309, France

Location

CH

Caen, 14033, France

Location

Hopital Percy

Clamart, 92141, France

Location

CHU

Créteil, 94010, France

Location

CHU

Dijon, 21034, France

Location

CH

Lens, 62307, France

Location

CHU

Lille, 59037, France

Location

CH

Limoges, 87042, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

CH

Meaux, 77104, France

Location

Hopital Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Saint-Louis

Paris, France

Location

CH

Roubaix, 59100, France

Location

CHU

Rouen, 76038, France

Location

CNLCC

Saint-Cloud, 92210, France

Location

CH

Valenciennes, 59322, France

Location

Hospital Central

Versailles, 78157, France

Location

IGR

Villejuif, 94805, France

Location

Related Publications (2)

  • Muresan B, Mamolo C, Cappelleri JC, Mokgokong R, Palaka A, Soikkeli F, Heeg B. Comparing cure rates for gemtuzumab ozogamicin plus standard chemotherapy vs standard chemotherapy alone in acute myeloid leukemia patients. Future Oncol. 2021 Aug;17(22):2883-2892. doi: 10.2217/fon-2020-1287. Epub 2021 Apr 16.

    PMID: 33858190DERIVED

  • Renneville A, Abdelali RB, Chevret S, Nibourel O, Cheok M, Pautas C, Dulery R, Boyer T, Cayuela JM, Hayette S, Raffoux E, Farhat H, Boissel N, Terre C, Dombret H, Castaigne S, Preudhomme C. Clinical impact of gene mutations and lesions detected by SNP-array karyotyping in acute myeloid leukemia patients in the context of gemtuzumab ozogamicin treatment: results of the ALFA-0701 trial. Oncotarget. 2014 Feb 28;5(4):916-32. doi: 10.18632/oncotarget.1536.

    PMID: 24659740DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Daunorubicin

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Castaigne Sylvie, Professor

    Versailles Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2009

First Posted

June 25, 2009

Study Start

December 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

FR(19)