Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
239
1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks
375 mg/m\^2 administered via intravenous infusion on Cycle 1 Day 1. 1400 mg injected under the skin (subcutaneous) permitted every 3 weeks from Cycle 2 Day 1 through end of treatment.
20 mg given by mouth (orally) daily
Administered via intravenous infusion every 3 weeks
Central Alabama Research
Birmingham, Alabama, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Florida Cancer Specialists
Bonita Springs, Florida, United States
Florida Cancer Specialists
Bradenton, Florida, United States
Overall survival (OS)
OS is defined as the time from the date of randomization to date of death due to any cause
Time frame: Approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. Assessment of PD will be performed by the investigator based on the Lugano Criteria for Response Assessment (Cheson 2014)
Time frame: Approximately 1 year
Objective response rate (ORR)
Proportion of participants with best response of complete response (CR) or partial response (PR) according to investigator assessment per the Lugano Criteria for Response Assessment (Cheson 2014).
Time frame: Approximately 1 year
Complete response (CR) rate
Proportion of participants with best response of CR according to investigator assessment per the Lugano Criteria for Response Assessment (Cheson 2014)
Time frame: Approximately 1 year
Duration of response (DOR)
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression by investigator assessment per the Lugano Criteria for Response Assessment (Cheson 2014) or death due to any cause, whichever occurs first.
Time frame: Approximately 1 year
Incidence of adverse events
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time frame: Approximately 1 year
OS in CD30+ participants
Time from the date of randomization to date of death due to any cause.
Time frame: Approximately 2 years
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Florida Cancer Specialists
Cape Coral, Florida, United States
Florida Cancer Specialists
Daytona Beach, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Naples, Florida, United States
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