NCT06626737

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

October 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

April 26, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

October 2, 2024

Last Update Submit

June 2, 2025

Conditions

Graft-versus-host Disease (GVHD)

Keywords

DapagliflozinGraft-versus-host diseaseAllogeneic hematopoietic cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of grade II-IV aGVHD

    estimated cumulative incidence of grade II-IV aGVHD at 100 days.

    100 days after transplantation.

Secondary Outcomes (8)

  • Cumulative incidence of grade III-IV aGVHD

    100 days after transplantation.

  • Neutrophil reconstitution

    up to 30 days.

  • Platelet reconstitution

    up to 100 days.

  • Cumulative incidence of chronic graft-versus-host disease (cGVHD)

    1 year after transplantation.

  • Overall survival

    1 year after transplantation.

  • +3 more secondary outcomes

Study Arms (1)

Dapagliflozin arm

EXPERIMENTAL

Participants will take Dapagliflozin10mg every day in -1 to 14 days.

Drug: Dapagliflozin (DAPA)

Interventions

Dapagliflozin (DAPA)DRUG

Participants will take Dapagliflozin 10mg every day in -1 to 14 days

Dapagliflozin arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36574342RESULT

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Yang XU

CONTACT

86-0512-67781850xuyang1020@126.com

Biqi ZHOU

CONTACT

86-0512-67781856zbq0903@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 4, 2024

Study Start

April 26, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)