Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial)
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
研究概览
简要总结
This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.
详细描述
Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle and/or with a high risk karyotype.
Optimization of the late consolidation therapy in standard risk patients (SR) by a prospective randomized trial comparing a high-dose cytarabine/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy with an autologous peripheral blood stem cell transplantation (PBSCT)
Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR
Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of de-novo AML, FAB M 1, 2, 4 - 7
- •diagnosis of secondary AML after chemo-/radiotherapy or MDS
- •diagnosis of RAEB-T
- •age between 16 and 60 years (including 60 years)
- •women after exclusion of pregnancy
- •written informed consent
排除标准
- •patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown III to IV)
- •patients with DLCO < 50%
- •patients with creatinine clearance < 60 ml/min
- •patients with bilirubin > 2mg% (34.2 mmol/L)
- •patients with severe complications of the leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock
- •patients with a psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participating in this study
- •HIV positivity
- •patients with a t(15;17) translocation
结局指标
主要结局
Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.
Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.
次要结局
- Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR.
- Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease.