A Phase II study of Panobinostat in Refactory de novo or secondary AML
Research type
Research Study
Full title
A Phase II Study of Oral Single Agent Panobinostat in Patients with Refractory de novo or secondary Acute Myelogenous Leukemia (AML)
IRAS ID
21082
Eudract number
2008-002983-32
Clinicaltrials.gov Identifier
Research summary
Acute Myeloid Leukaemia (AML) is the most common type of acute leukaemia in adults. This study will treat patients with AML in relapse. The expected survival time for a patient with relapsed AML is 3-12 months; there is no standard effective treatment for relapsed AML, a variety of treatment are currently in use but none have had a significant impact on patient outcome. The experimental drug being studied in this protocol is Panobinostat (LBH589) which is an oral treatment that has shown anti-tumour activity in both laboratory experiments and cancer patients.The purpose of this study is to assess the efficacy, safety and tolerability of Panobinostat in patients with refractory AML.All patients in this study (between 52 and 164 patients worldwide) will receive Panobinostat as the only treatment. They will receive the treatment orally three times a week for as long as they and their study doctor feel that they are benefiting. Patients will visit the study doctor on a regular basis for health checks, blood tests, bone marrow biopsy and ECG. A chest X-ray and either a cardiac ECHO or MUGA scan will be performed as part of the screening procedures.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
09/H1107/78
Date of REC Opinion
25 Sep 2009
REC opinion
Further Information Favourable Opinion