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Clinical trialNCT02683525CompletedPhase 2Interventional

Sitagliptin for Prevention of Acute Graft Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

SponsorSherif S. FaragEnrollment37Graft vs Host DiseaseHematopoietic Stem Cell Transplantation
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Primary Objective Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD prophylaxis. Secondary Objectives The following descriptive secondary objectives will be studied: 1. Describe the tolerability and potential toxicity of sitagliptin. 2. Describe the cumulative incidence of grades II-IV acute GvHD by day +100. 3. Describe the cumulative incidence of grades III-IV acute GvHD. 4. Describe the engraftment kinetics of absolute neutrophil count and platelets. 5. Describe the incidence of infections occurring during the 100 days post-transplant. 6. Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant. 7. Describe overall survival. 8. Describe the incidence of chronic GvHD. 9. Describe the cumulative incidence of relapse of the primary hematological malignancy.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Sherif Farag, MD, PhD

    Indiana University School of Medicine, Indiana University Simon Cancer Center

    Principal Investigator

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Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Indiana University Health Hospital

    Indianapolis, Indiana, United States

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

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Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
3 Feb 2016
Primary completion
13 Feb 2019
Completion
1 Oct 2019
Last update posted
22 Jan 2021
Registered enrollment
37
Registry id
NCT02683525

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.