A Phase 1/2 Multi-Center Trial of Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
Primary Objective
Phase 1: To determine the recommended phase 2 dose (RP2D) of vorinostat in children, adolescents and young adults following allogeneic HCT. Phase 2: To determine the incidence of grade 2‐4 acute GVHD by day +100 in subjects who receive vorinostat in addition to standard GVHD prophylaxis after allogeneic BMT.
Description
This is a prospective phase 1/2 trial designed to assess the hypothesis that vorinostat, in addition to standard graft versus host disease (GVHD) prophylaxis, is feasible and safe in children, adolescent and young adult patients. All subjects will undergo allogeneic BMT according to local site institutional practice.
Details
Locations
Childrens Hospital Colorado
Principal Investigator
Vanessa Fabrizio
Study ID
Protocol Number: 20-2018
More information available at ClinicalTrials.gov: NCT03842696
Categories
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