Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL
NCT ID: NCT00655837
Last Updated: 2014-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2008-04-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
SGN-40
4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
rituximab
375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
gemcitabine
1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
Interventions
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SGN-40
4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
rituximab
375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
gemcitabine
1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nancy Whiting, PharmD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of Colorado
Aurora, Colorado, United States
Oncology Specialists
Park Ridge, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Forero-Torres A, Bartlett N, Beaven A, Myint H, Nasta S, Northfelt DW, Whiting NC, Drachman JG, Lobuglio AF, Moskowitz CH. Pilot study of dacetuzumab in combination with rituximab and gemcitabine for relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2013 Feb;54(2):277-83. doi: 10.3109/10428194.2012.710328. Epub 2012 Sep 8.
Other Identifiers
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SG040-0008
Identifier Type: -
Identifier Source: org_study_id