Dapagliflozin to prevent acute graft-versus-host disease after allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives daily dapagliflozin to adults undergoing myeloablative allogeneic hematopoietic cell transplantation from haploidentical or unrelated donors, starting around day -1 through day +14. Participants receive standard graft-versus-host disease prophylaxis with cyclosporin A and methotrexate while researchers record incidence and severity of acute GVHD, hematopoietic recovery, survival outcomes, and adverse events. The study is single-center at The First Affiliated Hospital of Soochow University and includes patients aged 18–65 who can provide informed consent. Safety and tolerability are primary considerations alongside measuring cumulative incidence of aGVHD.

Why it matters

Who can join: the full rules

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).

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yang XU
• Email: xuyang1020@126.com
• Phone: 86-0512-67781850

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Post transplant cyclophosphamide, bortezomib, and sitagliptin to prevent graft-versus-host disease after allogeneic transplantation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.