A Phase Ib/II clinical evaluation of the safety and efficacy of combining panobinostat with 5-azacytidine in patients with high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukaemia (AML) that are unsuitable for standard induction chemotherapy.

The Alfred Hospital0 sites40 target enrollmentOctober 29, 2010

Overview

No summary available.

Registry

who.int

Start Date

October 29, 2010

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

The Alfred Hospital

•1\. Age greater than 55 years and/or unsuitable for standard AML\-type induction therapy
•2\. Provision of written informed consent
•3\. Patients with de novo (except Acute Promyelocytic Leukaemia) or secondary AML (including therapy\-related) as defined by the World Health Organisation Classification (WHO) or poor risk myelodysplasia (International Prognostic Scoring System for MDS score Int\-2 or High)
•4\. No previous chemotherapy other than hydroxyurea or thioguanaine which was ceased greater than 48 hours preceding commencement of study medication
•5\. Life expectancy of greater than 3 months in relation to diseases other then AML/MDS
•6\. Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2
•7\. Electrolyte levels (potassium, calcium (albumin\-adjusted), magnesium, phosphorous) within normal limits (WNL) or easily correctable with supplements
•8\. Adequate hepatic function as defined by bilirubin \= 2 times the upper limit of normal and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \= 3 times the upper limit of normal
•9\. Adequate renal function, with serum creatinine \= 1\.5 times the upper limit of normal
•10\. Patients with no uncontrolled active infection

•1\. Any serious medical or psychiatric conditions which the investigator feels may interfere with the patient’s ability to give informed consent or participate in the procedures or evaluations of the study
•2\. History of major non\-compliance to medication
•3\. Evidence of central nervous system (CNS) leukemia
•4\. Impaired cardiac function or clinically significant cardiac disease as follows:
•\*Left ventricular ejection fraction (LVEF) \<45% as determined by Multi Gated Acquisition scan (MUGA) scan or echocardiogram
•\*Complete left bundle branch block or right bundle branch block and left anterior hemiblock (bifascicular block)
•\* Obligate use of a cardiac pacemaker
•\* Congenital long QT syndrome or QTc \> 480 msec on the screening ECG
•\* Clinically significant resting bradycardia (\< 50 bpm)
•\* Angina pectoris or acute myocardial infarction 3 months prior to starting study drug