Graft-versus-host Disease (GVHD)
Conditions
Keywords
Dapagliflozin, Graft-versus-host disease, Allogeneic hematopoietic cell transplantation
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.
Interventions
Participants will take Dapagliflozin 10mg every day in -1 to 14 days
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of grade II-IV aGVHD | 100 days after transplantation. | estimated cumulative incidence of grade II-IV aGVHD at 100 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil reconstitution | up to 30 days. | time of neutrophil reconstitution. |
| Platelet reconstitution | up to 100 days. | time of platelet reconstitution. |
| Cumulative incidence of chronic graft-versus-host disease (cGVHD) | 1 year after transplantation. | estimated cumulative incidence of cGVHD at 1 year. |
| Cumulative incidence of grade III-IV aGVHD | 100 days after transplantation. | estimated cumulative incidence of grade III-IV aGVHD at 100 days. |
| Cumulative incidence of relapse | 1 year after transplantation. | estimated cumulative incidence of relapse at 1 year. |
| Graft-versus-host disease-free relapse-free survival (GRFS) | 1 year after transplantation. | estimated GRFS at 1 year. |
| Treatment related non-hematological grade 3 or higher adverse events | 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. |
| Overall survival | 1 year after transplantation. | estimated overall survival at 1 year. |
Countries
China
Contacts
Primary ContactYang XU
Backup ContactBiqi ZHOU
Outcome results
None listed