Sitagliptin for Prevention of Acute Graft Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Status:
Completed
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
Primary Objective
Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft
Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic
hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD
prophylaxis.
Secondary Objectives
The following descriptive secondary objectives will be studied:
1. Describe the tolerability and potential toxicity of sitagliptin.
2. Describe the cumulative incidence of grades II-IV acute GvHD by day +100.
3. Describe the cumulative incidence of grades III-IV acute GvHD.
4. Describe the engraftment kinetics of absolute neutrophil count and platelets.
5. Describe the incidence of infections occurring during the 100 days post-transplant.
6. Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant.
7. Describe overall survival.
8. Describe the incidence of chronic GvHD.
9. Describe the cumulative incidence of relapse of the primary hematological malignancy.