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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
United States, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Korea, Republic of, Netherlands, Poland, Spain, Switzerland, Taiwan, United Kingdom
EXPERIMENTAL: Experimental Arm
Brentuximab vedotin + lenalidomide + rituximab
DRUG: Brentuximab vedotin
1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeksDRUG: Rituximab
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.DRUG: Lenalidomide
20 mg given by mouth (orally) dailyACTIVE_COMPARATOR: Control Arm
Placebo + lenalidomide + rituximab
DRUG: Rituximab
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.DRUG: Lenalidomide
20 mg given by mouth (orally) dailyOTHER: Placebo
Administered via intravenous infusion every 3 weeksOverall survival (OS)
OS is defined as the time from the date of randomization to date of death due to any cause
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)
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).
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)
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.
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.
Approximately 1 year
OS in CD30+ participants
Time from the date of randomization to date of death due to any cause.
Approximately 2 years
240
Sponsor: Seagen Inc.
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: