Who is sponsoring NCT05149365?

NCT05149365 is sponsored by The First Affiliated Hospital of Soochow University.

What drugs are being tested in NCT05149365?

Interventions in NCT05149365: Sitagliptin + Standard Prophylaxis, Standard Prophylaxis.

What condition does NCT05149365 study?

NCT05149365 studies Acute-graft-versus-host Disease, Allogeneic Hematopoietic Stem Cell Transplantation.

Is NCT05149365 still recruiting?

NCT05149365 is currently completed. Last updated 10 February 2026.

Last reviewed 2026-02-10 · How we verify

NCT05149365: SHIELD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sitagliptin for Prevention of aGVHD After Alternative Donor Transplation

Completed Phase 3 Last updated 10 February 2026

What this trial tests

Phase 3 trial testing Sitagliptin + Standard Prophylaxis in Acute-graft-versus-host Disease in 190 participants. Completed in 16 June 2025.

Timeline

22 December 2021

Primary endpoint
24 September 2023

16 June 2025

Quick facts

Lead sponsor	The First Affiliated Hospital of Soochow University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	190
Start date	22 December 2021
Primary completion	24 September 2023
Estimated completion	16 June 2025
Sites	1 location across China

Drugs / interventions tested

Sitagliptin + Standard Prophylaxis — full drug profile →
Standard Prophylaxis — full drug profile →

Conditions studied

Acute-graft-versus-host Disease — all drugs for Acute-graft-versus-host Disease →
Allogeneic Hematopoietic Stem Cell Transplantation — all drugs for Allogeneic Hematopoietic Stem Cell Transplantation →

Sponsor

The First Affiliated Hospital of Soochow University

Who can join

Adults 18 to 60, any sex, with Acute-graft-versus-host Disease or Allogeneic Hematopoietic Stem Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Objective: It is hypothesized that the efficacy of Sitagliptin would reduce the incidence of grade II-IV acute Graft Versus Host Disease (GVHD) by day +100 post-transplant in patients undergoing alternative donor (related haploid or unrelated donor ) allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and receiving standard GVHD prophylaxis. Secondary Objectives The following descriptive secondary objectives will be studied: 1. Determine the tolerability and potential toxicity of sitagliptin in patients undergoing allogeneic HSCT. 2. Determine the cumulative incidence of grades II-IV acute GVHD by day +100. 3. To investigate the cumulative incidence of grades III-IV acute GVHD. 4. To investigate the engraftment kinetics of absolute neutrophil count and platelets. 5. To evaluate the incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and other infections occurring during the 100 days post-transplant. 6. To study non-relapse mortality (NRM) at day +100, and 1 year post-transplant. 7. Determine the overall survival at 1 year post-transplant. 8. Determine the incidence of chronic GVHD. 9. Determine the cumulative incidence of relapse of the primary hematological malignancy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Immunopathogenic mechanisms and modulatory approaches to graft-versus-host disease prevention in acute myeloid leukaemia.
Pang Y, Holtzman NG. · · 2023 · cited 3× · PMID 37353287 · DOI 10.1016/j.beha.2023.101475

Verify or expand the search:

Other recruiting trials for Acute-graft-versus-host Disease

Currently open trials in the same condition.

NCT05236062 — Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial · NA · recruiting
NCT03805789 — The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients · Phase 2, PHASE3 · active not recruiting

Other The First Affiliated Hospital of Soochow University trials

Trials by the same sponsor.

NCT07350863 — U69-CART-Cells For R/R T-ALL · Phase 1 · recruiting
NCT06985498 — Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL · Phase 2 · not yet recruiting
NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
NCT07511426 — U96-CAR-T-Cells For R/R B-ALL · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05149365 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University
Last refreshed: 10 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05149365.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing