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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 10
- 主要终点
- Event Free Survival (EFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •AML following previously know myeloproliferative syndrome.
- •Known central nervous system involvement.
- •Uncontrolled infection
- •Other active malignancy
研究组 & 干预措施
Arm A Daunorubicin and Cytarabine
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.
干预措施: conventional chemotherapy (AraC + Daunorubicin), (Drug)
Arm B Daunorubicin and Cytarabine and Mylotarg
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.
干预措施: Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin), (Drug)
结局指标
主要结局
Event Free Survival (EFS)
时间窗: Relapse or death measured from randomization
次要结局
- 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)