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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01196208
Expanded Access Status : No longer available
First Posted : September 8, 2010
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.

Tracking Information
First Submitted Date September 3, 2010
First Posted Date September 8, 2010
Last Update Posted Date September 21, 2020
 
Descriptive Information
Brief Title A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
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 Type Expanded Access
Intervention Drug: brentuximab vedotin
Every 21 days by intravenous infusion (1.8 mg/kg)
Other Name: SGN-35
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Belgium,   Bulgaria,   France,   Germany,   Hungary,   Italy,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01196208
Responsible Party Seagen Inc.
Study Sponsor Seagen Inc.
Collaborators Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Liga Ulmane, MD PSI Company Ltd.
PRS Account Seagen Inc.
Verification Date September 2020