Dapagliflozin in Allo-HCT for aGVHD
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
| Condition(s) | Graft-versus-host Disease (GVHD) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Soochow University |
| Locations | Suzhou, Jiangsu, China |
| Start date | 2025-04-26 |
| NCT ID | NCT06626737 |
| Official listing | https://clinicaltrials.gov/study/NCT06626737 |