Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL

Official Title

A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicentre, 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)

Summary:

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. Patients 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," patients and their doctors will not know whether a patient gets brentuximab vedotin or placebo. All patients in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL.

Trial Description

Primary Outcome:

• PFS per blinded independent central review (BICR) in the ITT population
• PFS per BICR in the CD30-positive population

• Objective response rate (ORR) per BICR
• Overall survival (OS) in the ITT population
• OS in the CD30+ population
• Complete response (CR) rate
• Duration of objective response
• Incidence of adverse events

View this trial on ClinicalTrials.gov