- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196208
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
September 17, 2020 updated by: Seagen Inc.
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
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
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 Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Melbourne, Australia, 3002
- Peter MacCallum Cancer Center
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Leuven, Belgium, 3000
- Leuven University Hospital
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Sofia, Bulgaria, 1527
- Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
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Sofia, Bulgaria, 1756
- Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
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Lyon, France, 69495
- South Lyon Hospital Center, Department of Dermatology
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Rouen, France, 76038
- Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
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Cedex 10
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Paris, Cedex 10, France, 75475
- Hopital Saint-Louis/Service d'Hematologie
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Minden, Germany, 32429
- Johannes Wesling Hospital Minden, Department of Dermatology
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Budapest, Hungary, 1097
- Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
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Debrecen, Hungary, 4004
- Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
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Szeged, Hungary, 6720
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
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Bologna, Italy, 40138
- Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"
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Genoa, Italy, 16132
- IRCCS University Hospital San Martino
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Lodz, Poland, 93-510
- Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
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Warsaw, Poland, 02-766
- Klinika Hematologii, Instytut Hematologii i Transfuzjologii
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Warsaw, Poland, 02-781
- Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
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Bucharest, Romania, 022328
- Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation
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Bucharest, Romania, 022328
- Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
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Judetul Mures
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Targu Mures, Judetul Mures, Romania, 540136
- Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
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Moscow, Russian Federation, 115478
- Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
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Moscow, Russian Federation, 125167
- Gematologicheskj nauchnyj centr RAMN
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Novosibirsk, Russian Federation, 630099
- Research Institute of Clinical Immunology
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St. Petersburg, Russian Federation, 197101
- Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
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Belgrade, Serbia, 11000
- Clinical Center of Serbia, Clinic of Hematology
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Madrid, Spain, 28033
- University Hospital 12 de Octubre, Department of Dermatology
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Zurich, Switzerland, 8091
- University Hospital Zurich, Department of Dermatology
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Birmingham, United Kingdom
- Queen Elizabeth Hospital
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London, United Kingdom
- St John's Institute of Dermatology
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California
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Stanford, California, United States, 94305
- Stanford Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Texas
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Houston, Texas, United States, 77030-4003
- MD Anderson Cancer Center / University of Texas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 3, 2010
First Submitted That Met QC Criteria
September 7, 2010
First Posted (Estimate)
September 8, 2010
Study Record Updates
Last Update Posted (Actual)
September 21, 2020
Last Update Submitted That Met QC Criteria
September 17, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, Large-Cell, Anaplastic
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Brentuximab Vedotin
Other Study ID Numbers
- SGN35-010
- 2010-020363-21 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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