Dapagliflozin for Preventing Acute Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation: A Prospective, Single-Arm Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Yang XU
xuyang1020@126.com
86-0512-67781850
Backup
Biqi ZHOU
zbq0903@126.com
86-0512-67781856
Time Frame
Start Date: 2025-04-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 72
Treatments
Experimental: Dapagliflozin arm
Participants will take Dapagliflozin10mg every day in -1 to 14 days.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov

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