Dapagliflozin in Allo-HCT for aGVHD
Recruiting now · Phase 2
Conditions studied: Graft-versus-host Disease (GVHD)
In brief
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 facts
- Study ID
- NCT06626737
- Run by
- The First Affiliated Hospital of Soochow University
- People needed
- 72
- Starts
- 2025-04-26
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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