Dapagliflozin in Allo-HCT for aGVHD | NCT06626737

Studies
Dapagliflozin in Allo-HCT for aGVHD

NCT06626737

Sponsor

The First Affiliated Hospital of Soochow University

Status

Recruiting

Last Update Posted

Jun 5, 2025Actual

Enrollment

72Estimated

Phase

Phase 2

Conditions

Graft-versus-host Disease (GVHD)

Interventions

Dapagliflozin (DAPA)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2025Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Oct 2, 2024

First Submission Date that Met QC Criteria

Oct 2, 2024

First Posted Date

Oct 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapagliflozin arm	Experimental	Participants will take Dapagliflozin10mg every day in -1 to 14 days.	Drug: Dapagliflozin (DAPA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin (DAPA)	Drug	Participants will take Dapagliflozin 10mg every day in -1 to 14 days	Dapagliflozin arm

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yang XU	Contact	86-0512-67781850		xuyang1020@126.com
Biqi ZHOU	Contact	86-0512-67781856		zbq0903@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Soochow University	Recruiting	Suzhou	Jiangsu	215000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36574342	Result	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.