Recruiting NCT06626737

Dapagliflozin in Allo-HCT for aGVHD

Phase II Interventional Graft-versus-host Disease (GVHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Dapagliflozin (DAPA).
Who it may be relevant to: Registry conditions: Graft-versus-host Disease (GVHD). Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

Drug Dapagliflozin (DAPA)
Participants will take Dapagliflozin 10mg every day in -1 to 14 days

Primary outcome measures

Cumulative incidence of grade II-IV aGVHD [Time frame: 100 days after transplantation.]

Secondary outcome measures (8)

Cumulative incidence of grade III-IV aGVHD [Time frame: 100 days after transplantation.]
Neutrophil reconstitution [Time frame: up to 30 days.]
Platelet reconstitution [Time frame: up to 100 days.]
Cumulative incidence of chronic graft-versus-host disease (cGVHD) [Time frame: 1 year after transplantation.]
Overall survival [Time frame: 1 year after transplantation.]
Cumulative incidence of relapse [Time frame: 1 year after transplantation.]
Graft-versus-host disease-free relapse-free survival (GRFS) [Time frame: 1 year after transplantation.]
Treatment related non-hematological grade 3 or higher adverse events [Time frame: up to 100 days.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Prevention

Study locations

China · 1 center

The First Affiliated Hospital of Soochow University — Suzhou

Publications

Cheng Q, Wang D, Lai X, Liu Y, Zuo Y, Zhang W, Lei L, Chen J, Liu H, Wang Y, Liu H, Zheng H, Wu D, Xu Y. The OTUD1-Notch2-ICD axis orchestrates allogeneic T cell-mediated graft-versus-host disease. Blood. 2023 Mar 23;141(12):1474-1488. doi: 10.1182/blood.2022017201. PMID 36574342

Identifiers

NCT: NCT06626737 · 2024348

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗