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

Dapagliflozin for Preventing Acute Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation: A Prospective, Single-Arm Study

This trial will test whether taking dapagliflozin around the time of an allogeneic stem cell transplant can lower the chance of acute graft-versus-host disease in adults with blood cancers.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chimeric antigen receptor, methotrexate
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06626737 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–65 with hematologic malignancies scheduled for myeloablative allogeneic HCT from a haploidentical or unrelated donor, who can take cyclosporin A and methotrexate and provide informed consent, are the intended candidates.

Not a fit: Patients with prior autologous or allogeneic HCT or CAR-T therapy, other active malignancies, type 1 diabetes or history of ketoacidosis, allergy to dapagliflozin, or recurrent urinary tract infections are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, dapagliflozin could reduce the occurrence of acute GVHD and improve transplant recovery and survival for eligible patients.

How similar studies have performed: Using SGLT2 inhibitors like dapagliflozin to prevent GVHD is a novel clinical application with limited direct clinical precedent, though these drugs are well-studied for cardiometabolic and renal benefits.

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).

Where this trial is running

Suzhou, Jiangsu

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

Study contacts

• Study coordinator: Yang XU

Conditions Graft-versus-host Disease; Dapagliflozin; Graft-versus-host disease; Allogeneic hematopoietic cell transplantation