Status:
NO_LONGER_AVAILABLE
A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Eligibility:
All Genders
6+ years
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01196208
Last Update
September 21 2020
Active Locations (31)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford Cancer Center
Stanford, California, United States, 94305
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4003
4
Peter MacCallum Cancer Center
Melbourne, Australia, 3002