Clinical Trials Search
Clinical Trial 18374
Interventions:Not Applicable; Panobinostat (LBH589)
Study Type: Prevention
Phase of Study: Phase II
- Lia Perez
A Phase II Trial Evaluating the use of a Histone Deacetylase Inhibitor Panobinostat for Graft Versus Host Disease (GVHD) Prevention
This study will test PANO in combination with tacrolimus/sirolimus (TAC/SIR) for acute GVHD prevention. The purpose of this study is to determine if Panobinostat (PANO) when used in combination with sirolimus and tacrolimus will help reduce the incidence of Graft-vs-host disease (GVHD).
To prospectively determine the cumulative incidence of acute GVHD grades II-IV by day 100 when combining PANO with standard combination of TAC/SIR for GVHD prevention. It is anticipated that the combination will decrease of acute GVHD risk to 30% compared to our historical control of 50% with TAC/SIR alone. Secondary: Cumulative incidence of chronic GVHD; Engraftment, relapse, non-relapse mortality, overall and relapse-free survival at one year. Biological studies to test the pharmacodynamics of TAC/SIR/PANO combination for GVHD prevention.