Sitagliptin for Prevention of aGVHD After Alternative Donor Transplantation

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title: Sitagliptin Efficacy and Safety for Prevention of Acute Graft Versus Host Disease in Patients Receiving Alternative Donor Allogeneic Hematopoietic Stem Cell Transplantation

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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 antithymocyte immunoglobulin (ATG)+cyclosporin A (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 reoccurrence. The specific reduction rate can be determined at each site; the patients with GVHD will be managed by routine practice in this site. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05149365
• Study type: Interventional
• Source: The First Affiliated Hospital of Soochow University
• Contact: Suning Chen, Professor
• Phone: 8613814881746
• Email: chensuning@sina.com
• Status: Recruiting
• Phase: Phase 3
• Start date: December 22, 2021
• Completion date: February 2024