A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old
- Conditions
- Acute Myeloid Leukemia
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- 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.
- 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 Overall Survival Survival from randomization Safety of the combination Mylotarg+chemotherapy Duration of study CR rate CR after induction Cumulative incidence of relapse Relapse from CR 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)
Hopital Percy
🇫🇷Clamart, France
CH
🇫🇷Valenciennes, France
CNLCC
🇫🇷Saint-Cloud, France
IGR
🇫🇷Villejuif, France
Hopital Avicenne
🇫🇷Bobigny, France
Hopital Edouard Herriot
🇫🇷Lyon, France
CHU
🇫🇷Rouen, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
Hopital Saint-Louis
🇫🇷Paris, France
Hospital Central
🇫🇷Versailles, France