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Completed

NCT Number: NCT01839097

Phase 1 Dose Finding Study of Belinostat 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.

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Key information

Conditions

Peripheral T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belinostat

Drug

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

CHOP

Drug

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, Vincristine, Doxorubicin, Prednisone

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Overall Response Rate

    Time frame: 126 days

    Overall response rate (ORR) after 6 cycles of BelCHOP regimen

  3. 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.

Sponsors and collaborators

Lead sponsor

Acrotech Biopharma Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2013
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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