Graft-versus-host Disease (GVHD)Phase 2DAPALAG-01NCT06626737
Dapagliflozin in Allo-HCT for aGVHD
A Phase 2 study testing Dapagliflozin (DAPA) in people with Graft-versus-host Disease (GVHD), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graft-versus-host Disease (GVHD)
- What is being tested?
- Dapagliflozin (DAPA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2025to 31 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Yang XU, 86-0512-67781850, xuyang1020@126.com
About this study
Official title: 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.
- Conditions
- Graft-versus-host Disease (GVHD)
- Being tested
- Dapagliflozin (DAPA)
- Keywords
- Dapagliflozin, Graft-versus-host disease, Allogeneic hematopoietic cell transplantation
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (DAPA)Drug
Participants will take Dapagliflozin 10mg every day in -1 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin arm | Experimental | Participants will take Dapagliflozin10mg every day in -1 to 14 days. Receives: Drug: Dapagliflozin (DAPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of grade II-IV aGVHD
estimated cumulative incidence of grade II-IV aGVHD at 100 days.
Measured: 100 days after transplantation.
Secondary outcomes (8)
Cumulative incidence of grade III-IV aGVHD
estimated cumulative incidence of grade III-IV aGVHD at 100 days.
Measured: 100 days after transplantation.
Neutrophil reconstitution
time of neutrophil reconstitution.
Measured: up to 30 days.
Platelet reconstitution
time of platelet reconstitution.
Measured: up to 100 days.
Cumulative incidence of chronic graft-versus-host disease (cGVHD)
estimated cumulative incidence of cGVHD at 1 year.
Measured: 1 year after transplantation.
Overall survival
estimated overall survival at 1 year.
Measured: 1 year after transplantation.
Cumulative incidence of relapse
estimated cumulative incidence of relapse at 1 year.
Measured: 1 year after transplantation.
Graft-versus-host disease-free relapse-free survival (GRFS)
estimated GRFS at 1 year.
Measured: 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.
Measured: up to 100 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start26 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft-versus-host Disease (GVHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626737
- Sponsor's protocol ID
- 2024348
- Acronym
- DAPALAG-01
- Status last verified
- Jun 2025
- First submitted
- 2 Oct 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36574342