Randomized Phase III Comparison of 12 Gy TBI and Cyclophosphamide 120 mg/kg With Fludarabine 120 mg/Sqm and 8 Gy TBI Before Allogeneic Transplantation in Patients With Acute Myeloid Leukemia in First Remission
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Treatment-related mortality at 12 months after transplantation
研究概览
简要总结
The primary goal of the study is to show that the treatment-related mortality of allogeneic hematopoietic stem cell transplantation an be significantly reduced by using a combination of 8 Gy total-body-irradiation and fludarabine in comparison to the conventional combination of 12 Gy TBI and 120 mg/kg Cyclophosphamide.
详细描述
Transplant-related deaths because of extramedullary toxicity and graft-versus host disease remain the major causes for treatment-failure in patients with AMl receiving allogeneic hematopoietic stem cell transplantation.
In phase II study, M . Stelljes and coworkers could show, that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages. The best results could be achieved in patients who had been in complete remission by the time of inclusion.
Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBI/Cyclophosphamide 120 mg/kg in patients ith AML in first remission.
After having achieved complete remission, and giving informed consent, patients are stratified according to marrow cytogenetics, age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies.
The primary end-point will be non-relapse mortality. The hypothesis would be, that the one-year mortality can be reduced from 25 to 15%. Given a power of 0.8 and a first-error of 5%, 252 patients will have to be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute myeloid leukemia in first remission
- •Standard-or high-risk marrow cytogenetics
- •HLA-matched related or unrelated donor available (in case of high-risk disease)
- •Age 18 to 60
- •Informed consent
- •Consent of donor to donate peripheral blood stem cells
- •sufficient liver function (elevation of transferases < 2.5 x upper limit)
排除标准
- •AML with t(5;17)
- •AML with t((8;21)
- •clinically relevant heart failure (NYHA II-IV)
- •Renal failure (creatinine > 200 µg/ml)
- •Liver function failure (bilirubin > 3 mg/dl)
- •Concomitant Neurological or psychiatric disease
- •Contraindications to receive prescribed study medication
- •HIV infection
- •Pregnancy
结局指标
主要结局
Treatment-related mortality at 12 months after transplantation
时间窗: 12 months
Proportion of patients dying without prior relapse
次要结局
- Disease-free and Overall survival(5 years)
- Grade 3-4 extramedullary toxicity(100 days)