Dapagliflozin in Allo-HCT for AGVHD

Phase 2

Not yet 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) 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 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

• Status Verified: 2024-10
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Study Start: 2024-11-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Age 18 to 65 years old.
• Patients with hematologic malignancies indicated for allo-HCT and having a suitable haploidentical 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
Neutrophil reconstitution	100 days after transplantation.	time of neutrophil reconstitution.
Platelet reconstitution	100 days after transplantation.	time of platelet 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.
Progression-free survival	1 year after transplantation.	estimated progression-free survival at 1 year
Graft-versus-host disease-free relapse-free survival (GRFS)	1 year after transplantation.	estimated GRFS at 1 year.

Trial Locations

Locations (1)

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