Phase II Trial of Inhibition Dipeptidyl Peptidase (DPP)-4 with Sitagliptin for the Prevention of Acute Graft versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Sherif Farag, MD
Primary Investigator
Overview
The purpose of this study is to learn in blocking a protein called DPP-4 with the drug sitagliptin in combination with standard sirolimus and tacrolimus therapy will prevent the development of graft-versus-host disease.
Description
The purpose of this study is to 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.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Graft vs Host Disease,Hematopoietic Stem Cell Transplantation
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Age: Between 18 Years - 60 Years
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Gender: All
Inclusion Criteria
Have acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplasia, chronic myelogenous leukemia, or aggressive non-Hodgkin's lymphoma
No uncontrolled bacterial, viral or fungal infection at time of enrollment
No HIV disease
Non-pregnant and non-nursing
Exclusion Criteria
Symptomatic uncontrolled coronary artery disease or congestive heart failure
Severe hypoxeima
Active central nervous system involvement
Prior allogenic or autologous hematopoietic stem cell transplant in past 12 months
Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
Have hypersensitivity to sitagliptin
Patients with current dependence on alcohol
