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.

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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
Age

Child to Adult

Eligibility

Patients 3 years to 39 years of age undergoing allogeneic BMT for malignant hematologic disease.

Please contact study team for additional information.

Type of Study

Treatment

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Vanessa Fabrizio,  MD, MS

Vanessa Fabrizio, MD, MS

Study ID

Protocol Number: 20-2018

More information available at ClinicalTrials.gov: NCT03842696

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