Lymphoma, Large-Cell, AnaplasticPhase 1NCT01309789
A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms
A Phase 1 study testing brentuximab vedotin, cyclophosphamide and prednisone in people with Lymphoma, Large-Cell, Anaplastic and Lymphoma, NK-cell, run by Seagen Inc. at 11 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large-Cell, Anaplastic, Lymphoma, NK-cell, Lymphoma, T-cell
- What is being tested?
- brentuximab vedotin, cyclophosphamide and prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Feb 2011to 28 Feb 2017
- 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
- Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
- Measurable disease of at least 1.5 cm
- ECOG performance status less than or equal to 2
Who cannot join
- Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
- Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
- History of another primary malignancy that has not been in remission for at least 3 years
- Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
- Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
- Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
City of Hope National Medical Center
Duarte, California, 91010
St. Francis Hospital
Greenville, South Carolina, 29601
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4000
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305
United Kingdom2 sites
Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma
The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
- Being tested
- brentuximab vedotin, cyclophosphamide, prednisone, doxorubicin, vincristine
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, monomethyl auristatin E, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-cell, Lymphoma, NK-cell
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Lymphoma, Lymphoma, T-Cell, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotinDrug
Also called SGN-35
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
cyclophosphamideDrug
750 mg/m2 IV every 3 weeks (Cycles 3-8)
brentuximab vedotinDrug
Also called SGN-35
1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
prednisoneDrug
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
cyclophosphamideDrug
750 mg/m2 IV every 3 weeks (Cycles 1-6)
doxorubicinDrug
50 mg/m2 IV every 3 weeks (Cycles 3-8)
doxorubicinDrug
50 mg/m2 IV every 3 weeks (Cycles 1-6)
prednisoneDrug
100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
vincristineDrug
1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sequential Receives: Drug: brentuximab vedotin; Drug: cyclophosphamide; Drug: prednisone; Drug: doxorubicin; Drug: vincristine |
| 2 | Experimental | Combination Receives: Drug: brentuximab vedotin; Drug: cyclophosphamide; Drug: doxorubicin; Drug: prednisone |
| 3 Brentuximab vedotin/CH-P | Experimental | Combination Receives: Drug: brentuximab vedotin; Drug: cyclophosphamide; Drug: doxorubicin; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and laboratory abnormalities
Measured: Through 1 month after last dose
Secondary outcomes (5)
Brentuximab vedotin concentration in blood
Measured: Through 1 month after last dose
Antitherapeutic antibodies in blood
Measured: Through 1 month after last dose
Best clinical response
Measured: Through 1 month after last dose
Progression-free survival
Measured: Until disease progression or study closure
Overall survival
Measured: Every 3 months until death or study closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2013
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large-Cell, AnaplasticStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Dana Kennedy, PharmD, BCOP, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309789
- Sponsor's protocol ID
- SGN35-011
- Other IDs
- 2010-022839-11
- Status last verified
- Jun 2017
- First submitted
- 25 Feb 2011
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
PubMed 25135998Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Uttarwar M, Lee SY, Ren H, Kennedy DA, Shustov AR. Five-year outcomes for frontline brentuximab vedotin with CHP for CD30-expressing peripheral T-cell lymphomas. Blood. 2018 May 10;131(19):2120-2124. doi: 10.1182/blood-2017-12-821009. Epub 2018 Mar 5.
PubMed 29507077
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01309789
- Acronym / sponsor ID
- SGN35-011
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, monomethyl auristatin E, Lymphoma, Large-Cell, Anaplastic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 7 Mar 2011 (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 purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: brentuximab vedotin, Drug: cyclophosphamide, Drug: prednisone, Drug: doxorubicin, Drug: vincristineSequential |
| 2 | Experimental | Drug: brentuximab vedotin, Drug: cyclophosphamide, Drug: doxorubicin, Drug: prednisoneCombination |
| 3 Brentuximab vedotin/CH-P | Experimental | Drug: brentuximab vedotin, Drug: cyclophosphamide, Drug: doxorubicin, Drug: prednisoneCombination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
- Measurable disease of at least 1.5 cm
- ECOG performance status less than or equal to 2
Key exclusion criteria (6 listed)
- Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
- Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
- History of another primary malignancy that has not been in remission for at least 3 years
- Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
- Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
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 |
|---|---|---|
| brentuximab vedotinAlso: SGN-351.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16) | Drug | 1 |
| cyclophosphamide750 mg/m2 IV every 3 weeks (Cycles 3-8) | Drug | 1 |
| brentuximab vedotinAlso: SGN-351.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16) | Drug | 2, 3 Brentuximab vedotin/CH-P |
| prednisone100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8) | Drug | 1 |
| cyclophosphamide750 mg/m2 IV every 3 weeks (Cycles 1-6) | Drug | 2, 3 Brentuximab vedotin/CH-P |
| doxorubicin50 mg/m2 IV every 3 weeks (Cycles 3-8) | Drug | 1 |
| doxorubicin50 mg/m2 IV every 3 weeks (Cycles 1-6) | Drug | 2, 3 Brentuximab vedotin/CH-P |
| prednisone100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6) | Drug | 2, 3 Brentuximab vedotin/CH-P |
| vincristine1.4 mg/m2 IV every 3 weeks (Cycles 3-8) | Drug | 1 |
Primary outcome
Incidence of adverse events and laboratory abnormalities
Time frame: Through 1 month after last dose
5 secondary outcomes
Brentuximab vedotin concentration in blood
Time frame: Through 1 month after last dose
Antitherapeutic antibodies in blood
Time frame: Through 1 month after last dose
Best clinical response
Time frame: Through 1 month after last dose
Progression-free survival
Time frame: Until disease progression or study closure
Overall survival
Time frame: Every 3 months until death or study closure
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 28 Jun 2017.
- Results publication: PubMed 25135998Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
- Derived from this study: PubMed 29507077Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Uttarwar M, Lee SY, Ren H, Kennedy DA, Shustov AR. Five-year outcomes for frontline brentuximab vedotin with CHP for CD30-expressing peripheral T-cell lymphomas. Blood. 2018 May 10;131(19):2120-2124. doi: 10.1182/blood-2017-12-821009. Epub 2018 Mar 5.
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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.
Dana Kennedy, PharmD, BCOP study director
Seagen Inc.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing brentuximab vedotin, cyclophosphamide and prednisone in people with Lymphoma, Large-Cell, Anaplastic and Lymphoma, NK-cell, run by Seagen Inc. at 11 sites in 2 countries.
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 3 inclusion and 6 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, United Kingdom. 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?
Incidence of adverse events and laboratory abnormalities (time frame: Through 1 month after last dose). 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 NCT01309789, which also lists 2 linked publications.
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 28 Jun 2017.