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, 94305
Investigator: Liza Wallace
Contact: 267-464-2575
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Investigator: Liza Wallace
Contact: 267-464-2575
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4003
Investigator: Liza Wallace
Contact: 267-464-2575
Investigator: David Fisher
Dmitry Yastrebov
41412281000
dmitry.yastrebov@psi-cro.com
Liga Ulmane, MD
Study Director
PSI Company Ltd.