Dapagliflozin in Allo-HCT for aGVHD

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called Dapagliflozin can help prevent a condition known as acute graft-versus-host disease (aGVHD) in patients receiving a specific type of stem cell transplant called allogeneic hematopoietic cell transplantation (allo-HCT). This condition can occur when the donor's immune cells attack the recipient's body. The trial will look at how effective Dapagliflozin is in reducing the number of patients who develop aGVHD and will also monitor any side effects or health issues that participants might experience while taking the medication. Participants will take Dapagliflozin daily for 14 days.

To be eligible for this trial, participants need to be between 18 and 65 years old and have certain blood cancers that require the transplant. They should also have a matching donor and be willing to undergo the necessary treatments before the transplant. Some health conditions, like having other types of cancer, certain infections, or severe organ problems, may prevent someone from joining the trial. The study is not yet recruiting participants, but if you or someone you know might be interested, they would need to sign a consent form and follow the study procedures. This trial aims to find better ways to protect patients during this critical treatment process.

Gender

ALL

Eligibility criteria

• 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).