This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
151
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Time frame: 9 weeks
Adverse events, laboratory values, and anti-drug antibody immune responses.
Time frame: 9 weeks
Partial response, failure free survival, overall survival, and response for one and two years following treatment.
Time frame: Every 3 months for 2 years
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100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California at Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
Christiana Care Health Systems
Newark, Delaware, United States
Georgetown University
Washington D.C., District of Columbia, United States
MD Anderson Cancer Center, Orlando
Orlando, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
...and 56 more locations