Status:
COMPLETED
A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
Lead Sponsor:
Seagen Inc.
Conditions:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part ...
Eligibility Criteria
Inclusion
- Histologically-confirmed NHL (DLBCL only for Parts B and C)
- Relapsed or refractory disease following at least 1 prior systemic therapy
- Measurable disease of at least 1.5 cm as documented by CT
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Exclusion
- History of another primary invasive malignancy that has not been in remission for at least 3 years
- Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
- B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
- Known cerebral/meningeal disease
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT01421667
Start Date
August 1 2011
End Date
June 1 2015
Last Update
November 28 2016
Active Locations (34)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
2
City of Hope
Duarte, California, United States, 91010-3000
3
PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
Oxnard, California, United States, 93030
4
Stanford Cancer Center
Stanford, California, United States, 94305-5821