Sitagliptin for Prevention of aGVHD After Alternative Donor Transplatation
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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
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