Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL)

The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.

This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose (MTD) of belinostat when administered in combination with CHOP.

Inclusion Criteria:

• Age 18 years or above
• Life Expectancy > 3 months
• Histologically confirmed diagnosis of PTCL
• Patients with transformed CTCL eligible for CHOP regimen
• Measurable disease based on Cheson 2007 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status < 2

Exclusion Criteria:

• Known active Hepatitis B/ Hepatitis C/ HIV infection
• Known, uncontrolled CNS metastases or primary CNS lymphoma
• Deep vein thrombosis diagnosed within 3 months
• Ongoing treatment for pre-existing cardiovascular disease
• Neuropathy Grade 3 or more
• Previous extensive radiotherapy except limited field RT for locally advanced nasal NK PTCL or for pain palliation
• Prior therapy with severely myelotoxic regimens, including autologous and allogenic stem cell transplantation
• Prior therapy with HDAC inhibitors (except for CTCL)
• Inadequate hematological, hepatic, or renal function