The OTUD1-Notch2-ICD axis orchestrates allogeneic T cell-mediated graft-versus-host disease.
Qiao Cheng, Dong Wang, Xiaoxuan Lai...
https://pubmed.ncbi.nlm.nih.gov/36574342Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
ID06626737
Dapagliflozin for Preventing Acute Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation: A Prospective, Single-Arm Study
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-06-05
72
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether Dapagliflozin can help prevent acute graft-versus-host disease (aGVHD) in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT) from haploidentical or unrelated donors. This study aims to understand if taking Dapagliflozin daily lowers the chances of developing aGVHD and to monitor safety and medical issues during this treatment. The trial is a phase 2, single-arm study led by The First Affiliated Hospital of Soochow University. Participants will take 10 mg of Dapagliflozin each day from one day before transplantation up to 14 days after. This treatment period is designed to assess the effect of Dapagliflozin on preventing aGVHD after allo-HCT. No placebo or comparison group is used; all enrolled participants receive the drug. During the study, researchers will monitor the occurrence and severity of aGVHD up to 100 days after transplantation, as well as the recovery of neutrophils and platelets, survival rates, relapse rates, and chronic graft-versus-host disease over one year. Safety will be evaluated by tracking treatment-related severe side effects up to 100 days. Participants will be followed closely during these periods to collect clinical data and assess outcomes related to the transplantation and the study drug.
CONDITIONS
Brief Title
Dapagliflozin in Allo-HCT for aGVHD
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 based on cyclosporin A and methotrexate.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Prior use of Dapagliflozin or other hypoglycemic medications allowed if physician approves switch.
- Ability to comply with study and follow-up procedures and signing informed consent.
You will not qualify if you...
- Presence of other malignancies.
- Prior history of autologous hematopoietic cell transplantation, allo-HCT, or chimeric antigen receptor T-cell therapy.
- Allergy to Dapagliflozin.
- Type 1 diabetes or history of ketoacidosis.
- History of recurrent urinary tract infections.
- Severe organ dysfunction.
- Active infection with hepatitis B, hepatitis C, or HIV.
- Pregnancy or breastfeeding.
- Any condition not suitable for the trial as determined by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 15 days
Participants take Dapagliflozin 10mg daily starting 1 day before transplantation until 14 days after transplantation to prevent acute graft-versus-host disease.
Daily medication with periodic visits during treatment
Follow-up
Duration - Up to 1 year
Participants are monitored for outcomes including acute and chronic graft-versus-host disease, blood cell recovery, survival, and adverse events up to 1 year after transplantation.
Regular visits over 1 year for assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
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Research Team
Y
Yang XU
B
Biqi ZHOU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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