A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: III
Principal Investigator: Bociek, R Gregory
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04404283?term=NCT04404283&draw=2&rank=1#eligibility
Summary
Primary Outcome Measures:
1. PFS per blinded independent central review (BICR) in the ITT population [ Time Frame: Up to 1 year ]
Time from the date of randomization to the date of first documentation of PD per BICR or to death due to any cause, whichever occurs first.
2. PFS per BICR in the CD30-positive population [ Time Frame: Up to 1 year ]
Time from the date of randomization to the date of first documentation of PD per BICR or to death due to any cause, whichever occurs first.
Secondary Outcome Measures
1. Objective response rate (ORR) per BICR [ Time Frame: Up to 1 year ]
Proportion of subjects with complete response (CR) or partial response (PR) according to the Lugano Criteria for Response Assessment (Cheson 2014).
2. Overall survival (OS) in the ITT population [ Time Frame: Up to 18 months ]
me from the date of randomization to date of death due to any cause.
3. OS in the CD30+ population [ Time Frame: Up to 18 months ]
Time from the date of randomization to date of death due to any cause.
4. Complete response (CR) rate [ Time Frame: Up to 1 year ]
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (Cheson 2014) or death due to any cause, whichever comes first.
5. Duration of objective response [ Time Frame: Up to 1 year ]
Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (Cheson 2014) or death due to any cause, whichever comes first.
6. Incidence of adverse events [ Time Frame: Up to 1 year ]