Sitagliptin for Prevention of aGVHD After Alternative Donor Transplatation

  • End date
    Dec 24, 2023
  • participants needed
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 24 March 2022


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.


This is a Prospective, Multi-center, Open-label, Randomized, Controlled clinical trial of Sitagliptin for the prevention and safety of aGVHD after Alternative Donor hematopoietic stem cell transplantation.

190 adult patients with hematologic malignancies receiving haploid or unrelated donor sourced HSCT are planned to be enrolled competitively in this study from 5 clinical centers in China. These patients will be randomly assigned to two groups of 95 patients each, which one is experimental group and the other is control group. 95 patients in experimental group will receive Sitagliptin combined with Standard prophylaxis for GVHD. 95 patients in the control group will receive Standard prophylaxis regimen for GVHD of Alternative Donor HSCT.

Control group uses ATG+CSA+MMF+MTX for GVHD prophylaxis with the details as follows: CSA 3mg/kg continuous i.v. drip, start before Day -7, change to p.o. when gastrointestinal function recovers with a dose of 5mg/kg as two divided doses, maintaining CSA within 150-250ng/ml(If CsA cannot be tolerated, tacrolimus may be used as an alternative.); MTX 15mg/m2,Day +1, 10mg/m2,Days +3, +6, and +11; MMF 0.5g BID, starting from Day -7 to day +30 for one month; ATG 2.5mg/kg/d, Day -4 to Day -1.

Experimental group will take Sitagliptin orally from d-1 to d+14 in addition to Standard Prophylaxis Regimen.

With regard to the content of dose reduction of CSA (including time and reduction rate), it is recommended for patients with hematologic malignancies in standard risk group to start to reduce dose after 3-6 months in the absence of GVHD and reoccurance. The specific reduction rate can be determined at each site; the patients with GVHD will be managed by routine practice in this site.

Condition Acute-graft-versus-host Disease, Allogeneic Hematopoietic Stem Cell Transplantation
Treatment Sitagliptin + Standard Prophylaxis, Standard Prophylaxis
Clinical Study IdentifierNCT05149365
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on24 March 2022


Yes No Not Sure

Inclusion Criteria

Patient age ≥ 18 to ≤ 60 years
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 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

Exclusion Criteria

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
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