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No Longer AvailableNCT01196208

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

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

Lead sponsor: Seagen Inc.•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

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.

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 21, 2020Terms

Trial snapshot

StatusNO_LONGER_AVAILABLE

Phase—

Enrollment—

Start date—

Last updatedSep 21, 2020

Condition

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

Locations shown

Stanford Cancer Center

Stanford, California

Dana-Farber Cancer Institute

Boston, Massachusetts

MD Anderson Cancer Center / University of Texas

Houston, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2020Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions