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

NCT02683525 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-01-22

Study results available
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Summary

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.

Conditions

  • Graft vs Host Disease
  • Hematopoietic Stem Cell Transplantation

Interventions

DRUG

Sitagliptin

600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant

Sponsors & Collaborators

  • Sherif S. Farag

    lead OTHER

Principal Investigators

  • Sherif Farag, MD, PhD · Indiana University School of Medicine, Indiana University Simon Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-03
Primary Completion
2019-02-13
Completion
2019-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02683525 on ClinicalTrials.gov