Disease, HodgkinNCT01196208
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
A study testing brentuximab vedotin in people with Disease, Hodgkin and Lymphoma, Large-Cell, Anaplastic, run by Seagen Inc. at 31 sites in 15 countries.
Trial summary
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001 Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
- What is being tested?
- brentuximab vedotin
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 31 sitesin 15 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
- Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin
Who cannot join
- History of another primary malignancy that has not been in remission for at least 3 years
- Known cerebral/meningeal disease
- Peripheral neuropathy of grade 2 or greater
- Females who are pregnant or breastfeeding
Trial locations and contacts
31 sites in 15 countries.
31 sites in 15 countries
Russia4 sites
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
Moscow, 115478
Gematologicheskj nauchnyj centr RAMN
Moscow, 125167
Research Institute of Clinical Immunology
Novosibirsk, 630099
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
Saint Petersburg, 197101
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4003
Stanford Cancer Center
Stanford, California, 94305
France3 sites
South Lyon Hospital Center, Department of Dermatology
Lyon, 69495
Hopital Saint-Louis/Service d'Hematologie
Paris, Cedex 10, 75475
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
Rouen, 76038
Hungary3 sites
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
Budapest, 1097
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
Debrecen, 4004
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged, 6720
Poland3 sites
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, 93-510
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
Warsaw, 02-766
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warsaw, 02-781
Romania3 sites
Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation
Bucharest, 022328
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
Bucharest, 022328
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
Târgu Mureş, Mureș County, 540136
Bulgaria2 sites
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
Sofia, 1527
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
Sofia, 1756
Italy2 sites
Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"
Bologna, 40138
IRCCS University Hospital San Martino
Genoa, 16132
United Kingdom2 sites
Queen Elizabeth Hospital
Birmingham
St John's Institute of Dermatology
London
Germany1 site
Johannes Wesling Hospital Minden, Department of Dermatology
Minden, 32429
Spain1 site
University Hospital 12 de Octubre, Department of Dermatology
Madrid, 28033
Switzerland1 site
University Hospital Zurich, Department of Dermatology
Zurich, 8091
About this study
Official title: An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001
Read the detailed description
The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.
- Conditions
- Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous
- Being tested
- brentuximab vedotin
- Keywords
- Disease, Hodgkin, Lymphoma, Monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Hematologic Diseases, Immunotherapy
- Medical subject headings
- Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous, Lymphoma, 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
Every 21 days by intravenous infusion (1.8 mg/kg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Liga Ulmane, MD, Study director, PSI Company Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196208
- Sponsor's protocol ID
- SGN35-010
- Other IDs
- 2010-020363-21
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2010
- Last updated
- 21 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01196208
- Acronym / sponsor ID
- SGN35-010
- Conditions
- Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous
- Keywords
- Disease, Hodgkin, Lymphoma, Monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Cutaneous, Lymphoma, Non-Hodgkin, Antibodies, Monoclonal, Antibody-Drug Conjugate
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- First posted
- 8 Sep 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 provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001
Detailed description
The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.
Study design
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
- Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin
Key exclusion criteria (4 listed)
- History of another primary malignancy that has not been in remission for at least 3 years
- Known cerebral/meningeal disease
- Peripheral neuropathy of grade 2 or greater
- Females who are pregnant or breastfeeding
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-35Every 21 days by intravenous infusion (1.8 mg/kg) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
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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.
Liga Ulmane, MD study director
PSI Company Ltd.
31 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brentuximab vedotin in people with Disease, Hodgkin and Lymphoma, Large-Cell, Anaplastic, run by Seagen Inc. at 31 sites in 15 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Russia, United States, France, Hungary, Poland and 10 more countries. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 21 Sep 2020.