A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),; Drug: conventional chemotherapy (AraC + Daunorubicin),

• Registration Number: NCT00927498
• Lead Sponsor: Acute Leukemia French Association

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.

Detailed Description

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.

Randomization will be centralized by phone :

Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and Mylotarg.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2009-04-29
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Primary Completion: 2011-07
• Status Verified: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B Daunorubicin and Cytarabine and Mylotarg	Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),	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 A Daunorubicin and Cytarabine	conventional chemotherapy (AraC + Daunorubicin),	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.

Primary Outcome Measures

Name	Time	Method
Event Free Survival (EFS)	Relapse or death measured from randomization

Secondary Outcome Measures

Name	Time	Method
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
Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML.	Duration of study

Trial Locations

Locations (10)

CH; 🇫🇷 Valenciennes, France

Hopital Avicenne; 🇫🇷 Bobigny, France

Hopital Percy; 🇫🇷 Clamart, France

CHU; 🇫🇷 Rouen, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

Hopital Pitie-Salpetriere; 🇫🇷 Paris, France

Hopital Saint-Louis; 🇫🇷 Paris, France

CNLCC; 🇫🇷 Saint-Cloud, France

Hospital Central; 🇫🇷 Versailles, France

IGR; 🇫🇷 Villejuif, France