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

Expanded access is currently available for this treatment.
Verified July 2015 by Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
First received: September 3, 2010
Last updated: July 31, 2015
Last verified: July 2015

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

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

Study Type: Expanded Access     What is 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

Resource links provided by NLM:

Further study details as provided by Seattle Genetics, Inc.:

Estimated Study Completion Date: August 2017
Intervention Details:
    Drug: brentuximab vedotin
    Every 21 days by intravenous infusion (1.8 mg/kg)
    Other Name: SGN-35
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.


Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participated in either the SGN35-005 or C25001 clincial 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warsaw, Poland, 02-781
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
Warsaw, Poland, 02-766
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
Gematologicheskj nauchnyj centr RAMN
Moscow, Russian Federation, 125167
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
Moscow, Russian Federation, 115478
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.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01196208     History of Changes
Other Study ID Numbers: SGN35-010, 2010-020363-21
Study First Received: September 3, 2010
Last Updated: July 31, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 06, 2015