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)
18 Years
N/A
Both
Peripheral T-cell Lymphoma
Trial Information
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)
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 or higher
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, and renal function
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD)
Outcome Description:
To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.
Outcome Time Frame:
up to 5 days
Safety Issue:
Yes
Principal Investigator
Petros G Nikolinakos, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northeast Georgia Cancer Care LLC
Authority:
United States: Food and Drug Administration
Study ID:
SPI-BEL-12-104
NCT ID:
NCT01839097
Start Date:
May 2013
Completion Date:
October 2014
Related Keywords:
- Peripheral T-cell Lymphoma
- PTCL
- Maximum Tolerated Dose
- Belinostat
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
Name | Location |
|---|---|
| Northeast Georgia Cancer Care, LLC | Athens, Georgia 30607 |
