Status:
COMPLETED
Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
Lead Sponsor:
Acrotech Biopharma Inc.
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01839097
Start Date
May 1 2013
End Date
January 1 2016
Last Update
January 3 2020
Active Locations (8)
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1
Yale University
New Haven, Connecticut, United States, 06511
2
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110