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

December 31, 2019 updated by: Acrotech Biopharma Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Georgia
      • Athens, Georgia, United States, 30607
        • Northeast Georgia Cancer Care, LLC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07962
        • Hematology - Oncology Associates of Northern NJ P.A
    • New York
      • New York, New York, United States, 10019
        • Columbia University Medical Center/Center for Lymphiod Malignancies
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Finding Phase

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.
Drug: Belinostat

Belinostat will be administered by intravenous infusion once daily for up to 5 days depending on the dose cohort as follows:

  • Cohort 1: belinostat 1000 mg/m2 IV on Day 1
  • Cohort 2: belinostat 1000 mg/m2 IV on Day 1-2
  • Cohort 3: belinostat 1000 mg/m2 IV on Day 1-3
  • Cohort 4: belinostat 1000 mg/m2 IV on Day 1-4
  • Cohort 5: belinostat 1000 mg/m2 IV on Day 1-5
Other Names:
  • PXD101
Drug: CHOP

Cyclophosphamide - 750 mg/m2 - IV - Day 1

Vincristine - 1.4 mg/m2 - IV - Day 1

Doxorubicin - 50mg/m2 - IV - Day 1

Prednisone 100mg PO - On Day 1 Prednisone will be administered after chemotherapy part of CHOP, and on Day 2-5 after belinostat.

Other Names:
  • Cyclophosphamide
  • Prednisone
  • Doxorubicin
  • Vincristine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: up to 5 days
To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.
up to 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerance
Time Frame: up to 5 days
To assess safety and tolerance of belinostat when given in combination with CHOP regimen. Safety and tolerance will be mainly characterized by the number and severity of treatment emergent adverse events, and treatment related AEs that occur or worsen after the first dose of study treatment.
up to 5 days
Overall Response Rate
Time Frame: 126 days
Overall response rate (ORR) after 6 cycles of BelCHOP regimen
126 days
Effectiveness of study drug
Time Frame: 126 days
Pharmacokinetics of belinostat when co-administered with CHOP regimen. The concentration of Belinostat to assess the effectiveness.
126 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acrotech Biopharma Inc.

Investigators

  • Study Director: Mi Rim Choi, MD, Spectrum Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 19, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-BEL-12-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral T-cell Lymphoma

Clinical Trials on Belinostat

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe