Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma

Inclusion Criteria

• Histologically confirmed Hodgkin or non Hodgkin's lymphoma
• Relapsed or refractory after standard treatments and with no curative option with conventional therapy
• No evidence of cerebral or meningeal involvement by lymphoma
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Life expectancy of at least 3 months
• Signed informed consent form prior to enrollment
• Patients must meet the following laboratory criteria: Aspartate aminotransferase (AST)/serum glutamate oxaloacetate transaminase (SGOT) and ALT/serum glutamate pyruvate transaminase (SGPT) /= 1.0 x 109/L, Platelets >/=100 x 109/L
• Fasting serum cholesterol 450 msec confirmed by the investigator prior to enrollment to the study • Patients with congenital long QT syndrome • History of sustained ventricular tachycardia • Any history of ventricular fibrillation or torsades de pointes • Bradycardia defined as heart rate = 50 beats per minute are eligible.
• Impaired cardiac function including any one of the following continued: • Patients with a myocardial infarction or unstable angina within 6 months from registration on study • Congestive heart failure (NY Heart Association class III or IV) • Right bundle branch block and left anterior hemiblock (bifascicular block) • Uncontrolled hypertension
• Concomitant use of drugs with a risk of causing torsades de pointes
• Patients with unresolved diarrhea Common Toxicity Criteria for Adverse Effects (CTCAE) grade 1
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral PANOBINOSTAT or everolimus.
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception.
• Male patients whose sexual partners are WOCBP not using effective birth control
• Patients with a history of another primary malignancy within 5 years other than curatively treated CIS of the cervix, basal or squamous cell carcinoma of the skin, or early stage prostate carcinoma.
• Patients with known positivity for human immunodeficiency virus (HIV) ) or hepatitis C; baseline testing for HIV and hepatitis C is not required
• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
• Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone 1.5 x ULN
• Active (acute or chronic) uncontrolled severe infection, requiring oral or intravenous antibiotics.
• Patients receiving treatment on another clinical research trial.