Chronic Graft-Versus-Host Disease Clinical Trial
Official title:
A Phase II Study of Panobinostat (LBH589) as Second-Line Therapy in Patients With Chronic Graft-Versus-Host Disease
There is a clear need for effective, steroid-sparing agents for the management of chronic
graft-versus-host disease (GVHD). Thus, agents like Histone deacetylase (HDAC) inhibitors,
with the potential of decreasing pro-inflammatory events leading to GVHD without affecting
graft-versus-leukemia (GVL), may have a central role in the prevention and treatment of
GVHD.
This study will look at the efficacy of panobinostat (LBH589), an HDAC inhibitor, in the
treatment of patients with chronic GVHD who have failed corticosteroids. In this group of
patients, effective steroid-sparing options are limited and are usually associated with
profound immunosuppression and decreased GVL effect.
Chronic GVHD is an autoimmune, inflammatory disorder that occurs in the majority of patients
who experience acute GVHD. Long-term corticosteroids are still standard therapy for chronic
GVHD. Corticosteroids are associated with high morbidity and non-relapse mortality. In
addition, corticosteroids are broadly immunosuppressive and can also decrease the GVL effect
and increase the incidence of relapse. There is a clear need for effective, steroid-sparing
agents for the management of chronic GVHD. Thus, agents like HDAC inhibitors, with the
potential of decreasing pro-inflammatory events leading to GVHD without affecting GVL, may
have a central role in the prevention and treatment of GVHD.
This study will look at the efficacy of panobinostat (LBH589), an HDAC inhibitor, in the
treatment of patients with chronic GVHD who have failed corticosteroids. In this group of
patients, effective steroid-sparing options are limited and are usually associated with
profound immunosuppression and decreased GVL effect.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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