A Study Of Panobinostat In Children With Refractory Hematologic Malignancies
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL),
Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL).
Panobinostat is a new drug that is considered investigational because it has not been
approved in the United States by the Food and Drug Administration (FDA), or in any other
country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene
expression found in cells causing them to stop growing or die. Panobinostat has been used in
several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has not
been given to children.
This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be
safely given. Drugs are given at gradually increasing dosages until there are unacceptable
side effects. The goal of the Phase I study is to find out the dose of panobinostat that can
be safely given to children with relapsed ALL, AML, HD and NHL.
Phase:
Phase 1
Details
Lead Sponsor:
Therapeutic Advances in Childhood Leukemia Consortium