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Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).
Official title: Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients: A Multicenter, Randomized Controlled, Open-Label, Phase 2 Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2025-07-24
Completion Date
2028-04-01
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
Immediate HSCT Group
Patients undergo direct allogeneic HSCT.
Bridging Therapy Group
Patients receive one to two cycles of bridging therapy before undergoing allogeneic HSCT. o Bridging Therapy Regimen: Hypomethylating agents (HMA) alone or HMA-based combination chemotherapy, e.g., azacitidine (AZA) 100 mg/day + venetoclax (VEN) 400 mg/day for 7 days. Targeted therapies (e.g., IDH1 inhibitors) will be used for eligible patients.
Locations (5)
Peking University People's Hospital
Beijin, Beijing Municipality, China
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, China
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shandong, China
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, China
The Second Hospital of Hebei Medical University
Shijia Zhuang, China