Clinical trial NCT01839097: Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral T-cell Lymphoma
Keywords: PTCL
Maximum Tolerated Dose
Belinostat
Lead sponsor: Acrotech Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: up to 5 days
Secondary outcomes:
measure: Safety and tolerance
timeFrame: up to 5 days
measure: Overall Response Rate
timeFrame: 126 days
measure: Effectiveness of study drug
timeFrame: 126 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Athens
country: United States
facility: Northeast Georgia Cancer Care, LLC
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology - Oncology Associates of Northern NJ P.A
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center/Center for Lymphiod Malignancies
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Spectrum Pharmaceuticals, Inc
name: Mi Rim Choi, MD
role: STUDY_DIRECTOR
References:
citation: Johnston PB, Cashen AF, Nikolinakos PG, Beaven AW, Barta SK, Bhat G, Hasal SJ, De Vos S, Oki Y, Deng C, Foss FM. Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma. Exp Hematol Oncol. 2021 Feb 18;10(1):15. doi: 10.1186/s40164-021-00203-8.