Development of a Multi-biomarker Panel for Prognostic Stratification and Treatment Response Prediction in Acute Graft Versus Host Disease of the Gut

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a life-saving treatment for many malignant hematologic diseases. Its curative potential is due to both high-dose chemotherapy and the graft-versus-host disease (GvHD) process, in which the donor's T cells recognize the recipient's tissue as foreign. However, GvHD is a potentially fatal complication that significantly affects both survival and quality of life. GvHD can be acute or chronic, and one of the main target organs involved in acute GvHD is the intestine, with a high rate of treatment failure and mortality. We expect to identify a set of biomarkers, both clinical and experimental, that will enable the stratification of patients based on prognosis and response to treatment in intestinal GvHD. The ultimate goal of the study is to integrate clinical, transplant, and biomarker data into a robust predictive algorithm. This tool will enable personalized therapeutic approaches based on early biomarkers, improving prognostic accuracy for patient outcomes and optimizing therapeutic strategies.

NCT Number	NCT07305090
Lead Sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions	Blood Cancer
Enrollment	90 participants
Start Date	2025-10-15
Primary Completion	2027-10-15 (estimated)
Study Completion	2028-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-09