The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Location status: Recruiting
Recruiting
NCT Number: NCT06626737
Dapagliflozin in Allo-HCT for aGVHD
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Dapagliflozin (DAPA)
DrugParticipants will take Dapagliflozin 10mg every day in -1 to 14 days
Primary outcomes
-
Cumulative incidence of grade II-IV aGVHD
Time frame: 100 days after transplantation.
estimated cumulative incidence of grade II-IV aGVHD at 100 days.
Secondary outcomes
-
Cumulative incidence of grade III-IV aGVHD
Time frame: 100 days after transplantation.
estimated cumulative incidence of grade III-IV aGVHD at 100 days.
-
Neutrophil reconstitution
Time frame: up to 30 days.
time of neutrophil reconstitution.
-
Platelet reconstitution
Time frame: up to 100 days.
time of platelet reconstitution.
-
Cumulative incidence of chronic graft-versus-host disease (cGVHD)
Time frame: 1 year after transplantation.
estimated cumulative incidence of cGVHD at 1 year.
-
Overall survival
Time frame: 1 year after transplantation.
estimated overall survival at 1 year.
-
Cumulative incidence of relapse
Time frame: 1 year after transplantation.
estimated cumulative incidence of relapse at 1 year.
-
Graft-versus-host disease-free relapse-free survival (GRFS)
Time frame: 1 year after transplantation.
estimated GRFS at 1 year.
-
Treatment related non-hematological grade 3 or higher adverse events
Time frame: up to 100 days.
Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.
Study contacts
Contact information is provided by the study sponsor or research team.
Biqi ZHOU
CONTACT
Yang XU
CONTACT
Sponsors and collaborators
Lead sponsor
The First Affiliated Hospital of Soochow University
Other
Registry information
Official study title
Dapagliflozin for Preventing Acute Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation: A Prospective, Single-Arm Study
Acronym: DAPALAG-01
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Oct 4, 2024
- Registry last updated
- Jun 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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