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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06918834
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

First listed
Apr 9, 2025
Start date
Jul 24, 2025
Status verified
Sep 2025
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
236 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate HSCT Group
  • Active Comparator: Bridging Therapy Group

Primary Outcome Measure

2-year Disease-Free Survival (DFS) post-HSCT [ Time Frame: 2-year ]

Central Contacts

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