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首页> 美国卫生研究院文献>other >Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 with Intermediate-2 and High Risk Myelodysplastic Syndrome Blood and Marrow Transplant Clinical Trials Network #1102 Study Rationale Design and Methods
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Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 with Intermediate-2 and High Risk Myelodysplastic Syndrome Blood and Marrow Transplant Clinical Trials Network #1102 Study Rationale Design and Methods

机译：多中心生物分配试验比较强度降低的同种异体造血细胞移植与50-75岁中度2和高危骨髓增生异常综合征血液和骨髓移植患者的甲基化治疗或最佳支持治疗的临床试验网络＃1102研究理由设计和方法

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The introduction of reduced intensity conditioning regimens (RIC) made it possible to offer allogeneic hematopoietic cell transplantation (alloHCT) to older patients with myelodysplastic syndromes (MDS). However, the relative risks and benefits of alloHCT compared to novel non-transplant therapies continue to be the source of considerable uncertainty. We will perform a prospective biologic assignment trial to compare RIC alloHCT to non-transplant therapies based on donor availability. Primary outcome is 3-year overall survival. Secondary outcomes include leukemia-free survival, quality of life, and cost-effectiveness. Four hundred patients will be enrolled over roughly 3 years. Planned subgroup analyses will evaluate key biologic questions, such as the impact of age & response to hypomethylating agents on treatment effects. Findings from this study potentially may set a new standard of care for older MDS patients who are considered candidates for alloHCT.
机译：降低强度调节方案（RIC）的引入使得有可能向患有骨髓增生异常综合症（MDS）的老年患者提供同种异体造血细胞移植（alloHCT）。然而，与新型非移植疗法相比，alloHCT的相对风险和收益仍然是相当不确定性的来源。我们将进行一项前瞻性生物学任务试验，以根据捐助者的可获得性将RIC alloHCT与非移植疗法进行比较。主要结局是3年总生存期。次要结果包括无白血病生存期，生活质量和成本效益。大约3年内将招募400名患者。计划中的亚组分析将评估关键的生物学问题，例如年龄和对次甲基化剂反应对治疗效果的影响。这项研究的结果可能为被认为是alloHCT候选药物的老年MDS患者树立新的护理标准。

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