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

NCT01196208 | Unknown

• 2 other identifiers: SGN35-0102010-020363-21
• Study Type: expanded_access
• Target: N/A
• Locations: 15 countries
• Sites: 31

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

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; Antigens, CD30; Hematologic Diseases; Immunotherapy

Interventions

brentuximab vedotin DRUG

Every 21 days by intravenous infusion (1.8 mg/kg)

Also known as: SGN-35

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seagen Inc.: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (31)

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MD Anderson Cancer Center / University of Texas

Houston, Texas, 77030-4003, United States

Location

Peter MacCallum Cancer Center

Melbourne, 3002, Australia

Location

Leuven University Hospital

Leuven, 3000, Belgium

Location

Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

Sofia, 1527, Bulgaria

Location

Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

Sofia, 1756, Bulgaria

Location

Hopital Saint-Louis/Service d'Hematologie

Paris, Cedex 10, 75475, France

Location

South Lyon Hospital Center, Department of Dermatology

Lyon, 69495, France

Location

Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

Rouen, 76038, France

Location

Johannes Wesling Hospital Minden, Department of Dermatology

Minden, 32429, Germany

Location

Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

Budapest, 1097, Hungary

Location

Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

Debrecen, 4004, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

Szeged, 6720, Hungary

Location

Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"

Bologna, 40138, Italy

Location

IRCCS University Hospital San Martino

Genoa, 16132, Italy

Location

Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

Lodz, 93-510, Poland

Location

Klinika Hematologii, Instytut Hematologii i Transfuzjologii

Warsaw, 02-766, Poland

Location

Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

Târgu Mureş, Mureș County, 540136, Romania

Location

Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation

Bucharest, 022328, Romania

Location

Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

Bucharest, 022328, Romania

Location

Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

Moscow, 115478, Russia

Location

Gematologicheskj nauchnyj centr RAMN

Moscow, 125167, Russia

Location

Research Institute of Clinical Immunology

Novosibirsk, 630099, Russia

Location

Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

Saint Petersburg, 197101, Russia

Location

Clinical Center of Serbia, Clinic of Hematology

Belgrade, 11000, Serbia

Location

University Hospital 12 de Octubre, Department of Dermatology

Madrid, 28033, Spain

Location

University Hospital Zurich, Department of Dermatology

Zurich, 8091, Switzerland

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

St John's Institute of Dermatology

London, United Kingdom

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Cutaneous; Lymphoma; Hematologic Diseases

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Liga Ulmane, MD

  PSI Company Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 8, 2010
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

SE (1); US (3); DE (1); HU (3); RO (3); CH (1); IT (2); PL (3); RU (4); FR (3); BU (2); BE (1); AU (1); ES (1); GB (2)