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NCT Number: NCT06918834

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

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).

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital, Beijin, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate HSCT Group

Other

Patients undergo direct allogeneic HSCT.

Bridging Therapy Group

Other

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.

Primary outcomes

  1. 2-year Disease-Free Survival (DFS) post-HSCT

    Time frame: 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

Secondary outcomes

  1. Cumulative Incidence of Allogeneic HSCT

    Time frame: The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.

    The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.

  2. Complete Remission (CR) or CR Equivalent Rate from Randomization

    Time frame: 2-year

    The percentage of patients achieving CR or CR equivalent, defined as the first documented occurrence.

  3. 2-year Overall Survival (OS) post-HSCT

    Time frame: 2-year

    Defined as the time from HSCT to death from any cause within two years.

  4. 2-year Leukemia-Free Survival (LFS) from Randomization

    Time frame: 2-year

    The time from randomization to the occurrence of disease progression, relapse, or death from any cause within two years.

  5. 2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization

    Time frame: 2-year

    Defined as the assessment of patient-reported QoL starting from randomization over a 2-year period, evaluated using the EORTC QLQ-C30 questionnaire.

  6. Molecular Clearance Rate

    Time frame: 2-year

    Molecular clearance was defined by two consecutive blood samples obtained at least 4 weeks apart after that were negative for driver mutations in a patient who had been positive before transplantation.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiang Erlie, doctor

CONTACT

[email protected]

+86-15122538106

Xiao Zhijian, doctor

CONTACT

[email protected]

+86-13821085716

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Acronym: ImmBridge

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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