A Multicenter Phase II Trial of Inhibition of CD26 Peptidase Using Sitagliptin to Enhance Engraftment After Umbilical Cord Blood Transplantation for Adults With Hematological Malignancies
Umbilical cord blood (UCB) is more commonly used for transplantation in children but is
being used in adults more often. However, because adults are larger than children, the
relatively smaller stem cell dose in UCB is major limitation for transplantation in adults
and engraftment can be delayed. This study is trying to find out if the drug sitagliptin can
be used to increase and speed up engraftment in adults receiving UCB transplantation.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The percent of subjects engrafting by day +30 after transplantation
The primary objective of this phase II study is to determine if systemic inhibition of CD26 can result in neutrophil engraftment in 70% or more of patients by day +30 after transplantation, with a rate of <50% considered unacceptable.
Day 0 to Day +30 post transplant
Sherif S Farag, M.B.B.S., Ph.D.
United States: Food and Drug Administration
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