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

• Conditions: Lymphoma, Non-Hodgkin; Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoma, T-Cell, Cutaneous

• Registration Number: NCT01196208
• Lead Sponsor: Seagen 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

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 Timeline

• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (31)

MD Anderson Cancer Center / University of Texas; 🇺🇸 Houston, Texas, United States

Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno; 🇧🇬 Sofia, Bulgaria

Centrum Onkologii Institut im. Marii Sklodowskiej-Curie; 🇵🇱 Warsaw, Poland

Clinical Center of Serbia, Clinic of Hematology; 🇷🇸 Belgrade, Serbia

Gematologicheskj nauchnyj centr RAMN; 🇷🇺 Moscow, Russian Federation

Leuven University Hospital; 🇧🇪 Leuven, Belgium

Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation; 🇷🇴 Bucharest, Romania

Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu; 🇷🇴 Bucharest, Romania

Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova; 🇷🇺 St. Petersburg, Russian Federation

University Hospital Zurich, Department of Dermatology; 🇨🇭 Zurich, Switzerland

Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania; 🇧🇬 Sofia, Bulgaria

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

Peter MacCallum Cancer Center; 🇦🇺 Melbourne, Australia

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont; 🇭🇺 Szeged, Hungary

Klinika Hematologii, Instytut Hematologii i Transfuzjologii; 🇵🇱 Warsaw, Poland

Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika; 🇭🇺 Debrecen, Hungary

Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular; 🇷🇴 Targu Mures, Judetul Mures, Romania

Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly; 🇭🇺 Budapest, Hungary

Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi; 🇵🇱 Lodz, Poland

Johannes Wesling Hospital Minden, Department of Dermatology; 🇩🇪 Minden, Germany

Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer; 🇫🇷 Rouen, France

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN; 🇷🇺 Moscow, Russian Federation

Research Institute of Clinical Immunology; 🇷🇺 Novosibirsk, Russian Federation

Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"; 🇮🇹 Bologna, Italy

IRCCS University Hospital San Martino; 🇮🇹 Genoa, Italy

South Lyon Hospital Center, Department of Dermatology; 🇫🇷 Lyon, France

St John's Institute of Dermatology; 🇬🇧 London, United Kingdom

Hopital Saint-Louis/Service d'Hematologie; 🇫🇷 Paris, Cedex 10, France

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University Hospital 12 de Octubre, Department of Dermatology; 🇪🇸 Madrid, Spain