Status:
COMPLETED
A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
Eligibility Criteria
Inclusion
- Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
- Documented anaplastic lymphoma kinase (ALK) status.
- Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
- Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
- Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
- At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.
Exclusion
- Previous treatment with brentuximab vedotin.
- Previously received an allogeneic transplant.
- Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
- Known cerebral/meningeal disease.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00866047
Start Date
March 1 2009
End Date
June 1 2016
Last Update
March 22 2017
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
2
Stanford University Medical Center
Palo Alto, California, United States, 94304
3
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
4
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136