NCT06626737 Dapagliflozin in Allo-HCT for aGVHD
| NCT ID | NCT06626737 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Graft-versus-host Disease (GVHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-04-26 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 72 participants in total. It began in 2025-04-26 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06626737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Graft-versus-host Disease (GVHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06626737 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06626737 currently recruiting?
Yes, NCT06626737 is actively recruiting participants. Contact the research team at xuyang1020@126.com for enrollment information.
Where is the NCT06626737 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT06626737 clinical trial?
NCT06626737 is sponsored by The First Affiliated Hospital of Soochow University. The trial plans to enroll 72 participants.