Sitagliptin for Prevention of aGVHD After Alternative Donor Transplation

NCT05149365 | Completed Phase 3

• 1 other identifier: SZ-GVHD 06
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine the tolerability and potential toxicity of sitagliptin in patients undergoing allogeneic HSCT.
2. 2.Determine the cumulative incidence of grades II-IV acute GVHD by day +100.
3. 3.To investigate the cumulative incidence of grades III-IV acute GVHD.
4. 4.To investigate the engraftment kinetics of absolute neutrophil count and platelets.
5. 5.To evaluate the incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and other infections occurring during the 100 days post-transplant.
6. 6.To study non-relapse mortality (NRM) at day +100, and 1 year post-transplant.
7. 7.Determine the overall survival at 1 year post-transplant.
8. 8.Determine the incidence of chronic GVHD.
9. 9.Determine the cumulative incidence of relapse of the primary hematological malignancy.

Conditions

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

Keywords

Sitagliptin; Alternative Donor

Outcome Measures

Primary Outcomes (1)

• Development Grade II-IV Acute GVHD by Day +100 Following Transplantation

  Percent of patients and the 95% Confidence interval who have Grade II-IV Acute GVHD by 100 days following transplantation. Only patients who were on the study for at least 100 days post transplantation were included in the analysis.

  up to 100 days

Secondary Outcomes (10)

• Development Grade II-IV Acute GVHD at Day +100

  100 days from transplant

• Percentage of Patients With Grade III-IV Acute GVHD at Day +100

  100 days from transplant

• Cumulative incidence of early transplant-related death (TRM) within 100 days after transplantation

  100 days from transplant

• Median Time to Engraftment of Neutrophils

  up to 1 month

• Median Time to Engraftment of Platelets

  up to 4 months

Study Arms (2)

Sitagliptin Group

EXPERIMENTAL

95 adult patients with hematologic malignancies receiving Alternative Donor HSCT, who will receive Sitagliptin combined with Standard prophylaxis regimen for GVHD of Alternative Donor HSCT.

Drug: Sitagliptin + Standard Prophylaxis

Standard Group

ACTIVE COMPARATOR

95 adult patients with hematologic malignancies receiving Alternative Donor HSCT, who will only receive Standard prophylaxis regimen for GVHD of Alternative Donor HSCT

Drug: Standard Prophylaxis

Interventions

Standard Prophylaxis DRUG

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

Also known as: Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin

Standard Group

Sitagliptin + Standard Prophylaxis DRUG

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

Also known as: Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin

Sitagliptin Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age ≥ 18 to ≤ 60 years
• Eastern Cooperative Oncology Group (ECOG）score 0-2 points / Karnofsky score ≧80
• To receive allogeneic hematopoietic stem cell transplantation from related haploid or unrelated donor
• The pretreatment of modified Bu/Cy+ATG scheme was planned.
• Patients with malignant hematological diseases indicated by transplantation and in complete remission (CR) state.
• Expected survival ≥ 3 months
• Signed written informed consent (Patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent)
• Agree to use effective contraception

You may not qualify if:

• Prior allogeneic hematopoietic stem cell transplant
• Allergy/intolerance to Sitagliptin
• There are contraindications for Sitagliptin use.
• Moderate or severe renal insufficiency
• Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
• Human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection
• Active infection that is difficult to control
• Vital organ function cannot tolerate transplantation
• Other malignant tumors outside the blood system, except the following diseases: malignant tumors that have been cured for 3 years without active lesions; Adequate treatment of non-melanoma skin cancer without active foci of malignant amygdala and carcinoma in situ
• There is evidence that may interfere with the study or make patients at risk of serious complications or medical conditions, including but not limited to serious cardiovascular diseases (such as New York heart association class III or IV heart disease over the past six months of myocardial infarction, unstable type of cardiac arrhythmias) or unstable angina and/or severe lung disease (e.g. History of severe obstructive pulmonary disease and symptomatic bronchospasm)
• Pregnant or lactating women
• Any life-threatening medical condition or organ system dysfunction considered by the investigator may endanger the patient's safety by interfering with the absorption or metabolism of sitagliptin or putting study results at unnecessary risk

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The Second People's Hospital of Huai'an: collaborator
• The First People's Hospital of Changzhou: collaborator
• Xinqiao Hospital of Chongqing: collaborator
• Shenzhen People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Interventions

Sitagliptin Phosphate; Cyclosporine

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Suning Chen, Professor

  The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Multi-center, Open-label, Randomized, Controlled Clinical Trial

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: December 22, 2021
• Primary Completion: September 24, 2023
• Study Completion: June 16, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-06

Locations

CN (1)