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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Peripheral T-cell Lymphoma

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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, LLCAthens, Georgia  30607