Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 47
- 主要终点
- To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
研究概览
简要总结
A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.
详细描述
The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60years and ≤ 75 years
- •primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
- •First complete remission following one or two cycles of induction chemotherapy
- •Chemotherapy was administered according to current participating cooperative group protocols
- •Karnofsky score ≥ 70
- •Written informed consent
排除标准
- •AML FAB M3
- •HIV positivity
- •Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
- •The second study exclusively concerns induction therapy
- •Consolidation cycle one and two are given according to the accredited study group policy
- •No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
- •Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted
研究组 & 干预措施
Transplant Arm
Hematopoietic cell transplantation after Reduced Intensity Conditioning
干预措施: hematopoietic cell transplantation (Procedure)
Conventional Chemotherapy
The non-transplant treatment approach for consolidation
干预措施: Non-Transplant treatment approach for consolidation (Drug)
结局指标
主要结局
To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
时间窗: 5 years
次要结局
- To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT(5 Years)