At a glance
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Phase II Trial of Inhibition of Dipeptidyl Peptidase (DPP)-4 With Sitagliptin for the Prevention of Acute Graft Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating Sitagliptin for Graft vs Host Disease and Hematopoietic Stem Cell Transplantation. Completed, enrolled 37 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant