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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years
• High relapse risk MDS, defined by:
‣ IPSS-R score ≥3.5.
⁃ IPSS-M stratification as intermediate-high, high, or very high risk.
• Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).
• Karnofsky Performance Status (KPS) ≥60.
• Signed informed consent.
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijin
People's Liberation Army The General Hospital of Western Theater Command
RECRUITING
Chengdu
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
RECRUITING
Jinan
The Second Hospital of Hebei Medical University
RECRUITING
Shijia Zhuang
Zhengzhou University First Affiliated Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jiang Erlie, doctor
jiangerlie@ihcams.ac.cn
+86-15122538106
Backup
Xiao Zhijian, doctor
xiaozhijian@ihcams.ac.cn
+86-13821085716
Time Frame
Start Date: 2025-07-24
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 236
Treatments
Experimental: Immediate HSCT Group
Active_comparator: Bridging Therapy Group
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China