NCT00927498

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

A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Acute Leukemia French Association · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-07-01
• Completion: 2013-07-01
• First posted: 2009-06-25
• Last updated: 2013-07-11

Locations

19 sites across 1 country: France