rhTPO + CsA Versus CsA Alone in the Treatment of Lower-risk MDS With Thrombocytopenia: a Single-center Randomized Controlled Trial

Peking Union Medical College Hospital0 个研究点目标入组 78 人开始时间: 2026年6月1日最近更新: 2026年6月17日

适应症

试验速览

阶段: 3 期
状态: 尚未招募
发起方: Peking Union Medical College Hospital
入组人数: 78

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

This study aims to compare the efficacy and safety of recombinant human thrombopoietin (rhTPO) + cyclosporine (CsA) and CsA monotherapy in the treatment of lower-risk myelodysplastic neoplasms with thrombocytopenia.

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

入选标准

•Age ≥ 18 years old;
•Confirmed diagnosis of lower-risk MDS;
•Platelet ≤ 30×109/L, or < 50×109/L and accompanied by bleeding events;
•Baseline liver and kidney functions <2 ULN;
•Signed the informed consent form;

排除标准

•History of leukemia or stem cell transplantation, treatment-related MDS or malignant tumors;
•With splenomegaly or myelofibrosis;
•Infections or bleeding that cannot be controlled by standard treatment;
•Any concurrent malignant tumors within the past 5 years, or basal cell carcinoma of the skin at the local site;
•History of thromboembolic events, heart attack or stroke and current use of anticoagulants;
•Previously received cyclosporine (CsA) or ATG within 6 months;
•Previously used IL-11, rhTPO or TPO-RA;
•Pregnant or lactating women;
•Participated in other clinical trials within 3 months.

研究者

发起方

Peking Union Medical College Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Bing Han

Professor

Peking Union Medical College Hospital

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