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

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

• Registration Number: NCT01196208
• Lead Sponsor: Seagen Inc.

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.

Study Timeline

• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (31)

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

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