Non Hodgkin Lymphoma Clinical Trial
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
Summary
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001
Full 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.
Eligibility Criteria
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
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There are 28 Locations for this study
Stanford California, 94305, United States
Boston Massachusetts, 02115, United States
Houston Texas, 77030, United States
Melbourne , 3002, Australia
Leuven , 3000, Belgium
Sofia , 1527, Bulgaria
Sofia , 1756, Bulgaria
Paris Cedex 10, 75475, France
Lyon , 69495, France
Rouen , 76038, France
Minden , 32429, Germany
Budapest , 1097, Hungary
Debrecen , 4004, Hungary
Szeged , 6720, Hungary
Bologna , 40138, Italy
Genoa , 16132, Italy
Lodz , 93-51, Poland
Warsaw , 02-76, Poland
Warsaw , 02-78, Poland
Targu Mures Judetul Mures, 54013, Romania
Bucharest , 02232, Romania
Bucharest , 02232, Romania
Moscow , 11547, Russian Federation
Moscow , 12516, Russian Federation
Novosibirsk , 63009, Russian Federation
St. Petersburg , 19710, Russian Federation
Belgrade , 11000, Serbia
Madrid , 28033, Spain
Zurich , 8091, Switzerland
Birmingham , , United Kingdom
London , , United Kingdom
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