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

Seagen

Status

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

Treatments: Drug: brentuximab vedotin

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01196208

SGN35-010

2010-020363-21 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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