Dapagliflozin in Allo-HCT for aGVHD

Phase 2RecruitingNCT06626737

The First Affiliated Hospital of Soochow University72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Graft-versus-host Disease (GVHD)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

Cumulative incidence of grade III-IV aGVHD

estimated cumulative incidence of grade III-IV aGVHD at 100 days.

Time frame: 100 days after transplantation.

Neutrophil reconstitution

time of neutrophil reconstitution.

Time frame: up to 30 days.

Platelet reconstitution

time of platelet reconstitution.

Time frame: up to 100 days.

Cumulative incidence of chronic graft-versus-host disease (cGVHD)

estimated cumulative incidence of cGVHD at 1 year.

Time frame: 1 year after transplantation.

Overall survival

estimated overall survival at 1 year.

Time frame: 1 year after transplantation.

Cumulative incidence of relapse

estimated cumulative incidence of relapse at 1 year.

Time frame: 1 year after transplantation.

Graft-versus-host disease-free relapse-free survival (GRFS)

estimated GRFS at 1 year.

Time frame: 1 year after transplantation.

Treatment related non-hematological grade 3 or higher adverse events

Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.

Time frame: up to 100 days.

Dapagliflozin in Allo-HCT for aGVHD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts