Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
1 other identifier
interventional
23
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2013
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2013
CompletedFirst Posted
Study publicly available on registry
April 24, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 3, 2020
December 1, 2019
2.7 years
April 9, 2013
December 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Safety and tolerance
up to 5 days
Overall Response Rate
126 days
Effectiveness of study drug
126 days
Study Arms (1)
Dose Finding Phase
EXPERIMENTALThis 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Yale University
New Haven, Connecticut, 06511, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Hematology - Oncology Associates of Northern NJ P.A
Morristown, New Jersey, 07962, United States
Columbia University Medical Center/Center for Lymphiod Malignancies
New York, New York, 10019, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Related Publications (1)
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.
PMID: 33602316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mi Rim Choi, MD
Spectrum Pharmaceuticals, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2013
First Posted
April 24, 2013
Study Start
May 1, 2013
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 3, 2020
Record last verified: 2019-12