NCT00927498 - A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old | Biotech Hunter

Enrollment

280

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2013

Conditions

Acute Myeloid Leukemia

Interventions

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."

Trial Locations (19)

14033

CH, Caen

21034

CHU, Dijon

59037

CHU, Lille

59100

CH, Roubaix

59322

CH, Valenciennes

62307

CH, Lens

69437

Hopital Edouard Herriot, Lyon

75651

Hopital Pitie-Salpetriere, Paris

76038

CHU, Rouen

77104

CH, Meaux

78157

Hospital Central, Versailles

87042

CH, Limoges

92141

Hopital Percy, Clamart

92210

CNLCC, Saint-Cloud

93309

Hopital Avicenne, Bobigny

94010

CHU, Créteil

94805

IGR, Villejuif

95107

CH, Argenteuil

Unknown

Hopital Saint-Louis, Paris