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Sitagliptin for Prevention of aGVHD After Alternative Donor Transplation

NCT05149365 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Acute-graft-versus-host Disease
  • Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

DRUG

Sitagliptin + Standard Prophylaxis

Sitagliptin 600 mg ever 12 hours orally will be given starting from the day before transplantation through day +14 after transplantation and Standard prophylaxis regimen

DRUG

Standard Prophylaxis

Standard prophylaxis regimen for GVHD of Alternative Donor HSCT, include Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The First People's Hospital of Changzhou

    collaborator OTHER

  • Xinqiao Hospital of Chongqing

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Suning Chen, Professor · The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2023-09-24
Completion
2025-06-16

Countries

  • China

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 NCT05149365 on ClinicalTrials.gov