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)

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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

Last updated:

6/10/2014

NCT ID:

NCT01839097

IRB Number:

13-005584