Disease, HodgkinPhase 1NCT01060904
A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
A Phase 1 study testing brentuximab vedotin, doxorubicin and vinblastine in people with Disease, Hodgkin, run by Seagen Inc. at 4 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Disease, Hodgkin
- What is being tested?
- brentuximab vedotin, doxorubicin and vinblastine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2010to Sep 2012
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group performance status <3
Who cannot join
- History of another primary malignancy that has not been in remission for at least 3 years
- Known cerebral/meningeal disease
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, 27599
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030
Mayo Clinic
Rochester, Minnesota, 55905
Canada1 site
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma
The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.
- Conditions
- Disease, Hodgkin
- Being tested
- brentuximab vedotin, doxorubicin, vinblastine, dacarbazine, bleomycin
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Hematologic Diseases, Immunotherapy, Lymphoma, monomethyl auristatin E
- Medical subject headings
- Hodgkin Disease, Hematologic Diseases, Lymphoma
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
0.6-1.2 mg/kg IV every 2 weeks
doxorubicinDrug
25 mg/m2 IV every 2 weeks
vinblastineDrug
6 mg/m2 IV every 2 weeks
dacarbazineDrug
375 mg/m2 IV every 2 weeks
bleomycinDrug
10 units/m2 IV every 2 weeks
brentuximab vedotinDrug
Also called SGN-35
0.9-1.2 mg/kg IV every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) Receives: Drug: brentuximab vedotin; Drug: doxorubicin; Drug: vinblastine; Drug: dacarbazine; Drug: bleomycin |
| 2 | Experimental | brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine) Receives: Drug: doxorubicin; Drug: vinblastine; Drug: dacarbazine; Drug: brentuximab vedotin |
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 (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionSep 2012
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 Disease, HodgkinStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Naomi Hunder, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060904
- Sponsor's protocol ID
- SGN35-009
- Status last verified
- Dec 2014
- First submitted
- 29 Jan 2010
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.
PubMed 24239220
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT01060904
- Acronym / sponsor ID
- SGN35-009
- Conditions
- Disease, Hodgkin
- Keywords
- Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Hematologic Diseases, Immunotherapy, Lymphoma, monomethyl auristatin E
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Feb 2010 (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 in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: brentuximab vedotin, Drug: doxorubicin, Drug: vinblastine, Drug: dacarbazine, Drug: bleomycinbrentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) |
| 2 | Experimental | Drug: doxorubicin, Drug: vinblastine, Drug: dacarbazine, Drug: brentuximab vedotinbrentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group performance status <3
Key exclusion criteria (2 listed)
- History of another primary malignancy that has not been in remission for at least 3 years
- Known cerebral/meningeal disease
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-350.6-1.2 mg/kg IV every 2 weeks | Drug | 1 |
| doxorubicin25 mg/m2 IV every 2 weeks | Drug | 1, 2 |
| vinblastine6 mg/m2 IV every 2 weeks | Drug | 1, 2 |
| dacarbazine375 mg/m2 IV every 2 weeks | Drug | 1, 2 |
| bleomycin10 units/m2 IV every 2 weeks | Drug | 1 |
| brentuximab vedotinAlso: SGN-350.9-1.2 mg/kg IV every 2 weeks | Drug | 2 |
Primary outcome
Incidence of adverse events and laboratory abnormalities
Time frame: Through 1 month after last dose
3 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
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 18 Dec 2014.
- Results publication: PubMed 24239220Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.
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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.
Naomi Hunder, MD study director
Seagen Inc.
4 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, doxorubicin and vinblastine in people with Disease, Hodgkin, run by Seagen Inc. at 4 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 2 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 NCT01060904, 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 18 Dec 2014.