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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Enrolling

Phase 2

Conditions

Myelodysplastic Syndromes

Treatments

Other: Bridging Therapy Group

Other: Immediate HSCT Group

Study type

Interventional

Funder types

Other

Identifiers

NCT06918834

IIT2025016

Details and patient eligibility

About

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).

Full 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 occur.

Enrollment

236 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.