Dapagliflozin in Allo-HCT for aGVHD

Phase 2

Recruiting

• Conditions: Graft-versus-host Disease (GVHD)
• Interventions: Drug: Dapagliflozin (DAPA)

• Registration Number: NCT06626737
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Study Start: 2025-04-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapagliflozin arm	Dapagliflozin (DAPA)	Participants will take Dapagliflozin10mg every day in -1 to 14 days.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of grade II-IV aGVHD	100 days after transplantation.	estimated cumulative incidence of grade II-IV aGVHD at 100 days.

Secondary Outcome Measures

Name	Time	Method
Platelet reconstitution	up to 100 days.	time of platelet reconstitution.
Cumulative incidence of relapse	1 year after transplantation.	estimated cumulative incidence of relapse at 1 year.
Graft-versus-host disease-free relapse-free survival (GRFS)	1 year after transplantation.	estimated GRFS at 1 year.
Treatment related non-hematological grade 3 or higher adverse events	up to 100 days.	Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.
Cumulative incidence of grade III-IV aGVHD	100 days after transplantation.	estimated cumulative incidence of grade III-IV aGVHD at 100 days.
Neutrophil reconstitution	up to 30 days.	time of neutrophil reconstitution.
Cumulative incidence of chronic graft-versus-host disease (cGVHD)	1 year after transplantation.	estimated cumulative incidence of cGVHD at 1 year.
Overall survival	1 year after transplantation.	estimated overall survival at 1 year.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China