Dapagliflozin in Allo-HCT for aGVHD (DAPALAG-01)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Graft-versus-host Disease (GVHD)
• Intervention / Treatment: Drug: Dapagliflozin (DAPA)

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang XU; Phone Number: 86-0512-67781850; Email: xuyang1020@126.com
• Study Contact Backup: Name: Biqi ZHOU; Phone Number: 86-0512-67781856; Email: zbq0903@126.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • the First Affiliated Hospital of Soochow University
      • Contact: Yang XU; Phone Number: 86-0512-67781850; Email: xuyang1020@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapagliflozin arm; Participants will take Dapagliflozin10mg every day in -1 to 14 days.	Drug: Dapagliflozin (DAPA); Participants will take Dapagliflozin 10mg every day in -1 to 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of grade II-IV aGVHD	estimated cumulative incidence of grade II-IV aGVHD at 100 days.	100 days after transplantation.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Publications and helpful links

General Publications

• Cheng Q, Wang D, Lai X, Liu Y, Zuo Y, Zhang W, Lei L, Chen J, Liu H, Wang Y, Liu H, Zheng H, Wu D, Xu Y. The OTUD1-Notch2-ICD axis orchestrates allogeneic T cell-mediated graft-versus-host disease. Blood. 2023 Mar 23;141(12):1474-1488. doi: 10.1182/blood.2022017201.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Dapagliflozin; Graft-versus-host disease; Allogeneic hematopoietic cell transplantation
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Dapagliflozin
• Other Study ID Numbers: 2024348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No