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

Completed · Phase 1

Conditions studied: Peripheral T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT01839097

Run by

Acrotech Biopharma Inc.

People needed

23

Starts

2013-05-01

Expected to finish

2016-01-01

Last updated by the study team

2020-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale University — New Haven, Connecticut, United States
• Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Hematology - Oncology Associates of Northern NJ P.A — Morristown, New Jersey, United States
• Columbia University Medical Center/Center for Lymphiod Malignancies — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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