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

Peripheral T-cell Lymphoma Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839097
• Other study ID #: SPI-BEL-12-104
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: December 2019
• Source: Acrotech Biopharma LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

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
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Acrotech Biopharma LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)	To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.	up to 5 days
Secondary	Safety and tolerance	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
Secondary	Overall Response Rate	Overall response rate (ORR) after 6 cycles of BelCHOP regimen	126 days
Secondary	Effectiveness of study drug	Pharmacokinetics of belinostat when co-administered with CHOP regimen. The concentration of Belinostat to assess the effectiveness.	126 days