Phase III Clinical Study of ME3208 in Patients with Steroid-Dependent/Resistant Chronic Graft Versus Host Disease

Meiji Seika Pharma Co.,Ltd.0 个研究点目标入组 20 人开始时间: 2021年12月21日最近更新: 2025年3月26日

试验速览

暂无简介。

•Patients who are able to provide written informed consent
•Patients who received allogeneic hematopoietic cell transplantation (aHCT)
•Patients diagnosed with moderate to severe chronic GVHD
•Patients defined as steroid-dependent/refractory chronic GVHD at any time point after aHCT
•Patients with the performance scale of 60 or more at baseline

•Patients with active acute GVHD
•Patients with post-transplant lymphoproliferative disease
•Patients with a severe past history or complications (malabsorption syndrome, poorly controlled psychiatric disease, coronary artery disease, etc.) that may affect the evaluation of this study as judged by the principal investigator or subinvestigator
•Patients who cannot maintain medication adherence as judged by the principal investigator or subinvestigator
•Patients for whom the principal investigator or subinvestigator judged that the implementation of this study is inappropriate

best overall response rate (best ORR)

Percentage of participants who achieve complete response (CR) or partial response (PR)

Safety

The safety are assessed by subjective symptoms, objective findings, physiological and clinical examinations.

发起方