Overview

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