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A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)
Sponsor: Abbisko Therapeutics Co, Ltd
Summary
This is a multicenter, single arm, open label phase II clinical study in China. This study will evaluate the efficacy and safety of ABSK021 (Pimicotinib) in the treatment of patients with cGvHD who failed first-line therapy.
Official title: A Multicenter, Single-arm, Open-label, Phase II Clinical Study. This Study Consisting of Part A and Part B to Evaluate the Efficacy and Safety of ABSK021 (Pimicotinib) in Patients With Chronic Graft Versus Host Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2023-05-30
Completion Date
2026-12-30
Last Updated
2024-08-12
Healthy Volunteers
No
Conditions
Interventions
ABSK021
Patients in each phase and dose group will receive continuous treatment with oral administration once a day for 28 days/cycle until conditions for treatment termination are met.
Locations (14)
Peking University People's Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of the Army Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong Provincial Peoplep's Hospital
Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
Zhujiang, Guangdong, China
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
The Fir St Affiliated Hospital,Zhejiang Univer Sity School of Medicine
Hangzhou, Jiangsu, China
The First affiliated hospital of SuZhou University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Teaching Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China