Dapagliflozin in Allo-HCT for aGVHD (DAPALAG-01)

Soochow University

Status and phase

Enrolling

Phase 2

Conditions

Graft-versus-host Disease (GVHD)

Treatments

Drug: Dapagliflozin (DAPA)

Study type

Interventional

Funder types

Other

Identifiers

NCT06626737

2024348

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).