Last updated on January 2020

Vorinostat for Graft vs Host Disease Prevention in Children Adolescents and Young Adults Undergoing Unrelated Donor Blood and Marrow Transplantation

Brief description of study

The purpose of this study is to determine the recommended phase 2 dose of the drug Vorinostat in children, adolescents and young adults following allogeneic HCT and determine whether the addition of Vorinostat to the standard preventive therapy (tacrolimus / methotrexate) will reduce the incidence of graft versus host disease (GVHD) following unrelated donor, myeloablative transplant in children, adolescents and young adults.

Detailed Study Description

All subjects will undergo unrelated donor allogeneic blood and marrow transplant (BMT) according to local site institutional practice. The preparative regimen will depend upon the subject's underlying disease, previous therapy, and comorbidities. GVHD prophylaxis will consist of standard post-transplant immunosuppression, including tacrolimus and methotrexate. Vorinostat will be administered at 30, 45 or 60 mg/m2 BID PO from 10 days prior to transplant (day -10), until day +100 post-transplant (110 total days of dosing).

Clinical Study Identifier: NCT03842696

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