The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001
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.
Drug: brentuximab vedotin
Every 21 days by intravenous infusion (1.8 mg/kg)
Other Name: SGN-35
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
Stanford Cancer Center
Stanford, California, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Peter MacCallum Cancer Center
Melbourne, Australia
Leuven University Hospital
Leuven, Belgium
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
Sofia, Bulgaria
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
Sofia, Bulgaria
Hopital Saint-Louis/Service d'Hematologie
Paris, Cedex 10, France
South Lyon Hospital Center, Department of Dermatology
Lyon, France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
Rouen, France
Johannes Wesling Hospital Minden, Department of Dermatology
Minden, Germany
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
Budapest, Hungary
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
Debrecen, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
Szeged, Hungary
Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"
Bologna, Italy
IRCCS University Hospital San Martino
Genoa, Italy
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
Warsaw, Poland
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
Targu Mures, Judetul Mures, Romania
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
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
Moscow, Russian Federation
Gematologicheskj nauchnyj centr RAMN
Moscow, Russian Federation
Research Institute of Clinical Immunology
Novosibirsk, Russian Federation
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
St. Petersburg, Russian Federation
Clinical Center of Serbia, Clinic of Hematology
Belgrade, Serbia
University Hospital 12 de Octubre, Department of Dermatology
Madrid, Spain
University Hospital Zurich, Department of Dermatology
Zurich, Switzerland
Queen Elizabeth Hospital
Birmingham, United Kingdom
St John's Institute of Dermatology
London, United Kingdom
Liga Ulmane, MD, Study Director
PSI Company Ltd.