Seattle Genetics, Inc.

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

Official Title: 
An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma
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.

Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous

Drug: brentuximab vedotin
Every 21 days by intravenous infusion (1.8 mg/kg)
Other Name: SGN-35

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

Eligibility Gender: 
Eligibility Age: 
Minimum: 6 Years
Australia, Belgium, Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Serbia, Spain, Switzerland, United Kingdom, United States

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

Liga Ulmane, MD
Study Director
PSI Company Ltd.

Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
EA Number: 
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
MeSH Terms: 
Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous, Lymphoma, Large-Cell, Anaplastic, Hodgkin Disease, Antibodies, Antibodies, Monoclonal
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