AML 2001: a Phase III Prospective Randomized Study Comparing One or Two High Dose Chemotherapy Regimen Followed by Autologous Stem Cell Transplantation (ASCT) as Consolidation Strategy for Adults Aged 15 to 60 With Acute Myeloid Leukemia (AML) in First Complete Remission (CR).rémission complète d'Une Leucémie Aiguë Myéloblastique
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 832
- 试验地点
- 1
研究概览
简要总结
First randomization:
After inclusion Use of Daunorubicin (arm D) or Idarubicin (arm I) as anthracyclin during all courses of chemotherapy (induction, consolidation courses before ASCT)
Second randomization:
After achieving 1st CR: all patients received non intensive consolidation course Familial HLA typing required for all patients
Patients with HLA-identical sibling:
Patients with very good prognostic factors (CBF leukemias, WBC < 30 giga/l at diagnosis, 1st CR after one induction course) = arm C: no allogeneic stem cell transplantation in 1st CR; received 2 more courses of intensive consolidation chemotherapy All others patients received an allogeneic transplant For patients aged less than 51 = arm M: upfront myeloablative conditioning regimen For patients aged over 51 and less than 61= arm m: intensive chemotherapy consolidation course.
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 15 to 60 years
- •Diagnosis untreated AML (FAB 0 to 2, 4 to 7): more than 20% marrow blasts according to WHO classification
- •Signed informed consent required
排除标准
- •AML3 subtype
- •Previous diagnosis of myelodysplastic syndrome (MDS) or myeloproliferative disease; patients with previous chemotherapy or radiotherapy were eligible if they had no previous diagnosis of MDS
- •Isolated extramedullary disease
- •Inadequate performance status (≥ 3), cardiac function (LVEF < 40%, severe arythmia or unstable coronary disease), renal function (creatininine > 150 µmol/l), liver functional tests (bilirubin > 35 µmol/l, liver enzymes > 4 times normal values); life expectancy < 3 months
- •Informed consent refusal
研究组 & 干预措施
Idarubicine
干预措施: Zavedos (Drug)
Daunorubicine
干预措施: Cerubidine (Drug)