Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2025-07-24
Last updated
2025-09-12
Condition(s) studied
Myelodysplastic Syndromes
Investigational drug(s) / intervention(s)
Immediate HSCT GroupBridging Therapy Group
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years
2. High relapse risk MDS, defined by:
* IPSS-R score ≥3.5.
* IPSS-M stratification as intermediate-high, high, or very high risk.
3. Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).
4. Karnofsky Performance Status (KPS) ≥60.
5. Signed informed consent.
Exclusion Criteria:
1. Severe organ dysfunction:
* Left ventricular ejection fraction \<50%.
* Oxygen supplementation requirement.
* Serum bilirubin \>1.5x upper limit of normal (unless due to Gilbert syndrome) or AST/ALT \>5x upper limit of normal.
* Estimated glomerular filtration rate (eGFR) \<50 mL/min.
2. History of prior allogeneic HSCT.
3. Any condition deemed unsuitable by the investigator.
Primary outcome measure(s)
2-year Disease-Free Survival (DFS) post-HSCT — 2-year Defined as the time from transplantation to two years post-HSCT, with primary events including death or failure to achieve CR or CR equivalent at the time of assessment
Trial sites (5)
Facility
City
Region
Status
Peking University People's Hospital
Beijin
Beijing Municipality
Recruiting
Zhengzhou University First Affiliated Hospital
Zhengzhou
Henan
Recruiting
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan
Shandong
Recruiting
People's Liberation Army The General Hospital of Western Theater Command
Chengdu
Sichuan
Recruiting
The Second Hospital of Hebei Medical University
Shijia Zhuang
China
Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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