Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients

Recruiting now · Phase 2

Conditions studied: Myelodysplastic Syndromes

In brief

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).

Key facts

Study ID

NCT06918834

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

236

Starts

2025-07-24

Expected to finish

2028-04-01

Last updated by the study team

2025-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking University People's Hospital — Beijin, Beijing Municipality, China (enrolling)
• Zhengzhou University First Affiliated Hospital — Zhengzhou, Henan, China (enrolling)
• The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army — Jinan, Shandong, China (enrolling)
• People's Liberation Army The General Hospital of Western Theater Command — Chengdu, Sichuan, China (enrolling)
• The Second Hospital of Hebei Medical University — Shijia Zhuang, China (enrolling)

Full record on ClinicalTrials.gov

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