Sitagliptin for Prevention of aGVHD After Alternative Donor Transplatation

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 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 CMV, 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; The First People's Hospital of Changzhou; The Second People's Hospital of Huai'an; Xinqiao Hospital of Chongqing
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

1. Patient age ≥ 18 to ≤ 60 years

2. ECOG score 0-2 points/Karnofsky score ≧80

3. To receive allogeneic hematopoietic stem cell transplantation from related haploid or unrelated donor

4. The pretreatment of modified Bu/Cy+ATG scheme was planned.

5. Patients with malignant hematological diseases indicated by transplantation and in CR state

6. Expected survival ≥ 3 months

7. 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)

8. Agree to use effective contraception

Exclusion Criteria:

1. Prior allogeneic hematopoietic stem cell transplant

2. Allergy/intolerance to Sitagliptin

3. There are contraindications for Sitagliptin use.

4. Moderate or severe renal insufficiency

5. Patients with diabetes mellitus requiring insulin secretagogues and/or insulin

6. Human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection

7. Active infection that is difficult to control

8. Vital organ function cannot tolerate transplantation

9. 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

10. 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)

11. Pregnant or lactating women

12. 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