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

N/ANo Longer AvailableNCT01196208

Seagen Inc.

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

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

Interventions

brentuximab vedotinDRUG

Every 21 days by intravenous infusion (1.8 mg/kg)

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (31)

Data from ClinicalTrials.gov

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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

...and 21 more locations