Dapagliflozin in Allo-HCT for aGVHD
ConditionGraft-versus-host Disease (GVHD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Soochow University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Dapagliflozin (DAPA)
DrugParticipants will take Dapagliflozin 10mg every day in -1 to 14 days
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: Dapagliflozin armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative incidence of grade II-IV aGVHD
estimated cumulative incidence of grade II-IV aGVHD at 100 days.
Time frame
100 days after transplantation.Secondary outcomes
1
Cumulative incidence of grade III-IV aGVHD
estimated cumulative incidence of grade III-IV aGVHD at 100 days.
Time frame
100 days after transplantation.2
Neutrophil reconstitution
time of neutrophil reconstitution.
Time frame
up to 30 days.3
Platelet reconstitution
time of platelet reconstitution.
Time frame
up to 100 days.4
Cumulative incidence of chronic graft-versus-host disease (cGVHD)
estimated cumulative incidence of cGVHD at 1 year.
Time frame
1 year after transplantation.Sponsors and contacts
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Source ClinicalTrials.gov