NCT06918834 Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
| NCT ID | NCT06918834 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Myelodysplastic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2025-07-24 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 236 participants in total. It began in 2025-07-24 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 syndrome (HR-MDS).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years 2. High relapse risk MDS, defined by: * IPSS-R score ≥3.5. * IPSS-M stratification as intermediate-high, high, or very high risk. 3. Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations). 4. Karnofsky Performance Status (KPS) ≥60. 5. Signed informed consent. Exclusion Criteria: 1. 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. 2. History of prior allogeneic HSCT. 3. Any condition deemed unsuitable by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06918834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelodysplastic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06918834 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06918834 currently recruiting?
Yes, NCT06918834 is actively recruiting participants. Contact the research team at jiangerlie@ihcams.ac.cn for enrollment information.
Where is the NCT06918834 trial being conducted?
This trial is being conducted at Beijin, China, Zhengzhou, China, Jinan, China, Chengdu, China and 1 additional location.
Who is sponsoring the NCT06918834 clinical trial?
NCT06918834 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 236 participants.