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Dapagliflozin in Allo-HCT for aGVHD

RecruitingPhase 2Ages 18 Years - 65 YearsAllThe First Affiliated Hospital of Soochow Universi…
NCT06626737 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 base on cyclosporin A and methotrexate. * With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. * Patients with prior use of Dapagliflozin or other hypoglycemic medications may switch to Dapagliflozin, contingent upon the treating physician's assessment of contraindications, will be eligible. * Signing an informed consent form, having the ability to comply with study and follow-up procedures. Exclusion Criteria: * With other malignancies. * With a previous history of autologous hematopoietic cell transplantation, allo-HCT or chimeric antigen receptor T-cell therapy. * With a history of allergies to Dapagliflozin. * With type 1 diabetes or a history of ketoacidosis. * With a history of recurrent urinary tract infections. * With severe organ dysfunction. * With active hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection. * In pregnancy or lactation period. * With any conditions not suitable for the trial (investigators' decision).
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What it tests

  • Dapagliflozin (DAPA)
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Where

1 site
The First Affiliated Hospital of Soochow University
Suzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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