NCT06918834RecruitingPhase 2
Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
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
Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 236 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 24 Jul 2025
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT06918834
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 236
- From 24 Jul 2025 to the primary completion date, 1 Apr 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior allogeneic HSCT.
Other illness
- Any condition deemed unsuitable by the investigator.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijin | China | Recruiting |
| People's Liberation Army The General Hospital of Western Theater Command Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijia Zhuang | China | Recruiting |
| Zhengzhou University - First Affiliated Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.