Status:
COMPLETED
Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate...
Eligibility Criteria
Inclusion
- Have a histologic diagnosis of DLBCL, including transformed histology and follicular grade 3 disease.
- Must have at least one site of biopsy-proven disease demonstrating both of the following: bidimensional measurable disease with the longest axis \>= 1.5cm by radiographic imaging or positive FDG-PET scan at baseline.
- Patients with DLBCL and who have either relapsed, refractory, or progressive disease following salvage therapy, OR relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy.
- Either fresh or archived tumor specimen must be available.
Exclusion
- Documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms.
- Patients who have received allogeneic stem cell transplant.
- Patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal PSA within 8 weeks of registration.
- Patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug.
- Patients with a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00655837
Start Date
April 1 2008
End Date
February 1 2010
Last Update
December 18 2014
Active Locations (9)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
2
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
3
University of Colorado
Aurora, Colorado, United States, 80045-0510
4
Oncology Specialists
Park Ridge, Illinois, United States, 60068