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

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