A Phase 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T Cell Non-Hodgkin Lymphoma

Exclusion Criteria

• •Diagnosis: progressive disease at transplant work-up
• •Prior therapy: prior autologous or allogeneic transplant
• •Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection
• •Inadequate performance status/organ function defined by DLCO \< 50% (adjusted for hgb), cardiac function as defined below, KPS \< 60%.
• •Pregnant or breast feeding. For males and females of child-producing potential, inability to use effective contraceptive methods during the study
• •Prior therapy with romidepsin
• •Central nervous system or meningeal involvement
• •Any known cardiac abnormalities such as:
• •* Congenital long QT syndrome
• •* QTc interval ≥ 500 milliseconds
• •* Myocardial infarction within 6 months of transplantation. Subjects with a history of myocardial infarction between 6 and 12 months prior to transplant who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
• •* Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
• •* Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Appendix 1) In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
• •* An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
• •* Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix 2) and/or ejection fraction \<40% by MUGA scan or \<50% by echocardiogram and/or MRI
• •* A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD)
• •* Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes