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

Acrotech Biopharma

Status and phase: Completed; Phase 1

Conditions: Peripheral T-cell Lymphoma

Treatments: Drug: CHOP; Drug: Belinostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT01839097

SPI-BEL-12-104

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 1 patient group

Dose Finding Phase

Experimental group

Description:

This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose of Belinostat when administered in combination with CHOP. In Part A of the study, up to three sequential dose cohorts will enroll a maximum of 6 patients each. Enrollment will begin with the enrollment of patients into Cohort 3. On Day 1 of each 21-day treatment cycle, the study treatment will start with belinostat followed by CHOP regimen.

Treatment:

Drug: CHOP

Drug: Belinostat