Status:
RECRUITING
Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
A total of 236 patients will be randomized in a 1:1 ratio into the immediate transplantation group (n=118) and the disease control group (n=118). The study will continue until at least 124 events occu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- History of prior allogeneic HSCT.
- Any condition deemed unsuitable by the investigator.
Key Trial Info
Start Date :
July 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT06918834
Start Date
July 24 2025
End Date
April 1 2028
Last Update
September 12 2025
Active Locations (5)
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1
Peking University People's Hospital
Beijin, Beijing Municipality, China, 100044
2
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, China, 450000
3
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shandong, China
4
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, China, 610083