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A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

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ClinicalTrials.gov Identifier: NCT01196208
Recruitment Status : Available
First Posted : September 8, 2010
Last Update Posted : September 11, 2017
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

Condition or disease Intervention/treatment
Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Drug: brentuximab vedotin

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
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

Intervention Details:
    Drug: brentuximab vedotin
    Every 21 days by intravenous infusion (1.8 mg/kg)
    Other Name: SGN-35

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196208

Contact: Dmitry Yastrebov 41412281000 dmitry.yastrebov@psi-cro.com

  Hide Study Locations
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305
Contact: Liza Wallace    267-464-2575    sgn35eap@psi-cro.com   
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Contact: Liza Wallace    267-464-2575    sgn35eap@psi-cro.com   
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4003
Contact: Liza Wallace    267-464-2575    sgn35eap@psi-cro.com   
Principal Investigator: David Fisher         
Peter MacCallum Cancer Center
Melbourne, Australia, 3002
Principal Investigator: Miles Prince         
Leuven University Hospital
Leuven, Belgium, 3000
Principal Investigator: Pascal Wolter         
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
Sofia, Bulgaria, 1527
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
Sofia, Bulgaria, 1756
Hopital Saint-Louis/Service d'Hematologie
Paris, Cedex 10, France, 75475
South Lyon Hospital Center, Department of Dermatology
Lyon, France, 69495
Principal Investigator: Stephane Dalle         
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
Rouen, France, 76038
Johannes Wesling Hospital Minden, Department of Dermatology
Minden, Germany, 32429
Principal Investigator: Rudolf Stadler         
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
Budapest, Hungary, 1097
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
Debrecen, Hungary, 4004
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged, Hungary, 6720
Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"
Bologna, Italy, 40138
Principal Investigator: Pierluigi Zinzani         
IRCCS University Hospital San Martino
Genoa, Italy, 16132
Principal Investigator: Angelo Michele Carella         
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
Warsaw, Poland, 02-766
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warsaw, Poland, 02-781
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
Targu Mures, judetul Mures, Romania, 540136
Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation
Bucharest, Romania, 022328
Principal Investigator: Alina Tanase         
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
Bucharest, Romania, 022328
Russian Federation
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
Moscow, Russian Federation, 115478
Gematologicheskj nauchnyj centr RAMN
Moscow, Russian Federation, 125167
Research Institute of Clinical Immunology
Novosibirsk, Russian Federation, 630099
Principal Investigator: Irina Kryuchkova         
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
St. Petersburg, Russian Federation, 197101
Clinical Center of Serbia, Clinic of Hematology
Belgrade, Serbia, 11000
Principal Investigator: Milena Todorovic         
University Hospital 12 de Octubre, Department of Dermatology
Madrid, Spain, 28033
University Hospital Zurich, Department of Dermatology
Zurich, Switzerland, 8091
Principal Investigator: Reinhard Dummer         
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Principal Investigator: Julia Scarisbrick         
St John's Institute of Dermatology
London, United Kingdom
Principal Investigator: Sean Whittaker         
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Liga Ulmane, MD PSI Company Ltd.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01196208     History of Changes
Other Study ID Numbers: SGN35-010
2010-020363-21 ( EudraCT Number )
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Seattle Genetics, Inc.:
Disease, Hodgkin
Monomethylauristatin E
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Hematologic Diseases

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs