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

Acute Leukemia French Association

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00927498

ALFA 0701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Arm A Daunorubicin and Cytarabine

Active Comparator group

Description:

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.

Treatment:

Drug: conventional chemotherapy (AraC + Daunorubicin),

Arm B Daunorubicin and Cytarabine and Mylotarg

Experimental group

Description:

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.

Treatment:

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