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Model-based adaptive phase I trial design of post-transplant decitabine maintenance in myelodysplastic syndrome

机译：骨髓增生异常综合征移植后地西他滨维持的基于模型的自适应I期试验设计

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摘要

BackgroundThis report focuses on the adaptive phase I trial design aimed to find the clinically applicable dose for decitabine maintenance treatment after allogeneic hematopoietic stem cell transplantation in patients with higher-risk myelodysplastic syndrome and secondary acute myeloid leukemia.

机译：背景本报告的重点是适应性I期试验设计，旨在寻找高风险骨髓增生异常综合症和继发性急性髓细胞性白血病患者接受异基因造血干细胞移植后地西他滨维持治疗的临床适用剂量。

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期刊名称 Journal of Hematology Oncology
作者
Seunghoon Han; Yoo-Jin Kim; Jongtae Lee; Sangil Jeon; Taegon Hong; Gab-jin Park; Jae-Ho Yoon; Seung-Ah Yahng; Seung-Hwan Shin; Sung-Eun Lee; Ki-Seong Eom; Hee-Je Kim; Chang-Ki Min; Seok Lee; Dong-Seok Yim;
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作者单位

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年(卷),期 2015(8),-1
年度 2015
页码 118
总页数 9
原文格式 PDF
正文语种
中图分类肿瘤学;血液学检验;
关键词
Model-based drug development Adaptive design Myelodysplastic syndrome Population pharmacokinetics-pharmacodynamics Phase I clinical trial;

机译：基于模型的药物开发;适应性设计;骨髓增生异常综合症;人群药代动力学-药效学;I期临床试验;

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专利

1. Model-based adaptive phase I trial design of post-transplant decitabine maintenance in myelodysplastic syndrome [J] . Seunghoon Han, Yoo-Jin Kim, Jongtae Lee, Journal of Hematology and Oncology . 2015,第1期

机译：骨髓增生异常综合症移植后地西他滨维持的基于模型的自适应I期试验设计
2. FINAL Results of an Phase, Multicenter, Randomied, Controlled OPEN LEVEL Trial: Decitabine Therapy in Patients with Myelodysplastic Syndromes [J] . Shao Zonghong, Liu Hui, Jiang Hao, Blood: The Journal of the American Society of Hematology . 2018,第NovaelaTreatmentAppr期

机译：阶段，多中心，随机，受控开放水平试验的最终结果：骨髓增强综合征患者的甲二腺素治疗
3. A phase 1 clinical trial of vorinostat in combination with decitabine in patients with acute myeloid leukaemia or myelodysplastic syndrome. [J] . Mark Kirschbaum, Ivana Gojo, Stuart L Goldberg, British Journal of Haematology . 2014,第2期

机译：伏立诺他联合地西他滨在急性髓性白血病或骨髓增生异常综合症患者中进行的一项1期临床试验。
4. Adaptive Enrichment Design: Development and Methodology - An Adaptive Approach Using a Phase 3 Clinical Trial with Two Subpopulations in a Confirmatory Setting [C] . Shariq Alavi, Rika Alavi, Pranab Ghosh, Molecular Medicine TRI-CON. . 2014

机译：自适应浓缩设计：开发和方法 - 一种使用阶段3临床试验的适应性方法，在确认设置中的两个亚步骤
5. Model-based designs for phase I cancer clinical trials. [D] . Chu, Pei-Ling. 2005

机译：用于I期癌症临床试验的基于模型的设计。
6. Design and rationale of the QUAZAR Lower-Risk MDS (AZA-MDS-003) trial: a randomized phase 3 study of CC-486 (oral azacitidine) plus best supportive care vs placebo plus best supportive care in patients with IPSS lower-risk myelodysplastic syndromes and poor prognosis due to red blood cell transfusion–dependent anemia and thrombocytopenia [O] . Guillermo Garcia-Manero, Antonio Almeida, Aristoteles Giagounidis, 2016

机译：QUAZAR低风险MDS（AZA-MDS-003）试验的设计和原理：对IPSS低危型骨髓增生异常患者进行CC-486（口服阿扎胞苷）加最佳支持治疗与安慰剂加最佳支持治疗的随机3期研究依赖红细胞的贫血和血小板减少症引起的综合征和预后不良
7. Model-based adaptive phase I trial design of post-transplant decitabine maintenance in myelodysplastic syndrome [O] . Seunghoon Han, Yoo-Jin Kim, Jongtae Lee, 2015

机译：骨髓增生异常综合征移植后地西他滨维持的基于模型的自适应I期试验设计

Model-based adaptive phase I trial design of post-transplant decitabine maintenance in myelodysplastic syndrome

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