CLINICAL TRIAL: SUBJECTS WITH (MDS) RECEIVING HYPOMETHYLATIN AGENTS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项II期、多中心、随机化、双盲、安慰剂对照、同步治疗组、AMG 531剂量探索研究，旨在评估AMG 531降低接受低甲基化药物治疗的低风险或中等风险MDS受试者中临床显著性血小板减少事件发生率的活性。 通过骨髓活检诊断为MDS且国际预后评分系统（IPSS）评级为低、中-1或中-2风险MDS且计划接受至少4个周期的低甲基化剂治疗其疾病的MDS受试者适合筛选本研究。 本研究将由A部分和B部分组成。除低甲基化药物给药外，A部分和B部分所有访视的检查和程序均相同。A部分的受试者将接受试验用药物联合氮杂胞苷治疗。 B部分的受试者将接受试验用药物联合地西他滨治疗。在开放部分B进行入组之前，将完成部分A并进行评价。 B部分的剂量将由数据审查小组（DRT）在审查A部分的分析后确定。 A部分和B部分的分析将使用相同的终点和分析方法进行。 本研究的总估计持续时间为24个月，所有研究中心（美国约60家研究中心）将入组最多315例患者（A部分264例，B部分51例）。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a Phase 2 multi-center, randomized, double-blind, placebo-controlled, simultaneous treatment group, dose finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving a hypomethylating agent. Subjects with MDS diagnosed by a bone marrow biopsy and an International Prognostic Scoring System (IPSS) rating of low, intermediate-1 or intermediate-2 risk MDS that are planned to receive at least four cycles of a hypomethylating agent for treatment of their disease are appropriate to screen for this study. This study will be composed of a part A and a part B. The tests and procedures for all visits will be the same in part A and part B except for the administration of the hypomethylating agent. Subjects in part A will receive investigational product in combination with azacytidine. Subjects in part B will receive investigational product in combination with decitabine. Part A will be completed and evaluated prior to opening part B for enrollment. The dose for part B will be determined by the Data Review Team (DRT) after their review of the analysis of part A. The analysis of Part A and Part B will be conducted using the same endpoints and methods of analysis. The total estimated duration of the study is 24 months and a maximum of 315 patients ( 264 in part A and 51 subjects in part B) will be enrolled in all sites which will be approximately 60 centers in the United States.