A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Celgene2 个研究点分布在 1 个国家目标入组 25 人开始时间: 2002年2月1日最近更新: 2019年11月8日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Celgene
入组人数: 25
试验地点: 2

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.
•Baseline mean hemoglobin < 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.
•More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.
•Women must not be pregnant or lactating
•No use of another experimental study drug within 30 dy\ays of baseline
•Understand and sign written informed consent
•Able to adhere to study visit schedule, understand and comply with other protocol requirements.

排除标准

未提供

研究者

发起方

Celgene

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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