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Dapagliflozin in Allo-HCT for aGVHD

Dapagliflozin in Allo-HCT for aGVHD

Recruiting
18-65 years
All
Phase 2

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Overview

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.

Eligibility

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).

Study details
    Graft-versus-host Disease (GVHD)

NCT06626737

The First Affiliated Hospital of Soochow University

18 June 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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