Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06626737

Dapagliflozin in Allo-HCT for aGVHD

Led by The First Affiliated Hospital of Soochow University · Updated on 2025-06-05

72

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dapagliflozin in Allo-HCT for aGVHD

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years old
  • Patients with hematologic malignancies indicated for allo-HCT and having a suitable haploidentical or unrelated donor
  • Willing to undergo myeloablative conditioning and graft-versus-host disease prophylaxis based on cyclosporin A and methotrexate
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
  • Prior use of Dapagliflozin or other hypoglycemic medications allowed if switching to Dapagliflozin is approved by the treating physician
  • Ability to provide informed consent and comply with study and follow-up procedures
Not Eligible

You will not qualify if you...

  • Having other malignancies
  • Previous history of autologous hematopoietic cell transplantation, allo-HCT, or chimeric antigen receptor T-cell therapy
  • Allergy to Dapagliflozin
  • Type 1 diabetes or history of ketoacidosis
  • History of recurrent urinary tract infections
  • Severe organ dysfunction
  • Active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
  • Pregnancy or breastfeeding
  • Any condition deemed unsuitable for the trial by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

Y

Yang XU

CONTACT

B

Biqi ZHOU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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