Peripheral T-cell LymphomaPhase 1NCT01839097
Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
A Phase 1 study testing Belinostat and CHOP in people with Peripheral T-cell Lymphoma, run by Acrotech Biopharma Inc. at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Belinostat and CHOP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2013to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607
Duke University Medical Center
Durham, North Carolina, 27705
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hematology - Oncology Associates of Northern NJ P.A
Morristown, New Jersey, 07962
Yale University
New Haven, Connecticut, 06511
Columbia University Medical Center/Center for Lymphiod Malignancies
New York, New York, 10019
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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)
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.
Read the 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.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Belinostat, CHOP
- Keywords
- PTCL, Maximum Tolerated Dose, Belinostat
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelinostatDrug
Also called PXD101
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
CHOPDrug
Also called Cyclophosphamide, Vincristine, Doxorubicin, Prednisone
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Finding Phase | Experimental | 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. Receives: Drug: Belinostat; Drug: CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.
Measured: up to 5 days
Secondary outcomes (3)
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.
Measured: up to 5 days
Overall Response Rate
Overall response rate (ORR) after 6 cycles of BelCHOP regimen
Measured: 126 days
Effectiveness of study drug
Pharmacokinetics of belinostat when co-administered with CHOP regimen. The concentration of Belinostat to assess the effectiveness.
Measured: 126 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mi Rim Choi, MD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839097
- Sponsor's protocol ID
- SPI-BEL-12-104
- Status last verified
- Dec 2019
- First submitted
- 9 Apr 2013
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33602316
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01839097
- Acronym / sponsor ID
- SPI-BEL-12-104
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- PTCL, Maximum Tolerated Dose, Belinostat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Finding Phase | Experimental | Drug: Belinostat, Drug: CHOPThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelinostatAlso: PXD101Belinostat 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 | Drug | Dose Finding Phase |
| CHOPAlso: Cyclophosphamide, Vincristine, Doxorubicin, PrednisoneCyclophosphamide - 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. | Drug | Dose Finding Phase |
Primary outcome
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.
3 secondary outcomes
Safety and tolerance
Time frame: up to 5 days
Overall Response Rate
Time frame: 126 days
Effectiveness of study drug
Time frame: 126 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Derived from this study: PubMed 33602316Johnston 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mi Rim Choi, MD study director
Spectrum Pharmaceuticals, Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belinostat and CHOP in people with Peripheral T-cell Lymphoma, run by Acrotech Biopharma Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01839097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.