Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
NCT ID: NCT06918834
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
236 participants
INTERVENTIONAL
2025-07-24
2028-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate HSCT Group
Immediate HSCT Group
Patients undergo direct allogeneic HSCT.
Bridging Therapy Group
Bridging Therapy Group
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.
Interventions
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Immediate HSCT Group
Patients undergo direct allogeneic HSCT.
Bridging Therapy Group
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.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Locations
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Peking University People's Hospital
Beijin, Beijing Municipality, China
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, China
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shandong, China
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, China
The Second Hospital of Hebei Medical University
Shijia Zhuang, , China
Countries
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Central Contacts
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Facility Contacts
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Hao Jiang
Role: primary
FANG ZHOU
Role: primary
Other Identifiers
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IIT2025016
Identifier Type: -
Identifier Source: org_study_id
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