Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
NCT ID: NCT01839097
Last Updated: 2020-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2013-05-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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, 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
18 Years
ALL
No
Sponsors
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Acrotech Biopharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mi Rim Choi, MD
Role: STUDY_DIRECTOR
Spectrum Pharmaceuticals, Inc
Locations
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Yale University
New Haven, Connecticut, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, 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
Columbia University Medical Center/Center for Lymphiod Malignancies
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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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.
Other Identifiers
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SPI-BEL-12-104
Identifier Type: -
Identifier Source: org_study_id
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