Dapagliflozin in Allo-HCT for aGVHD

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06626737
Phase
PHASE2
Status
Recruiting
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Conditions

  • Graft-versus-host Disease (GVHD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to learn if Dapagliflozin could prevent acute graft-versus-host disease (aGVHD) in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT) with haploidentical or unrelated donor and to assess its safety. The main questions it aims to answer are: Dose Dapagliflozin lower the cumulative incidence of aGVHD? What medical problems do participants undergoing allo-HCT from haploidentical or unrelated donor have when taking Dapagliflozin? Researchers will document the occurrence of graft-versus-host disease, hematopoietic reconstitution, survival rates and adverse effects. Participants will take Dapagliflozin every day in -1 to 14 days.

Key Dates

Start date
Apr 26, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Dapagliflozin arm
    Participants will take Dapagliflozin10mg every day in -1 to 14 days.

Primary Outcome Measure

Cumulative incidence of grade II-IV aGVHD [ Time Frame: 100 days after transplantation. ]

Central Contacts

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