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)

The University of Virginia Cancer Center seeks adults age 18 or older with diffuse large B-cell lymphoma for a research study. Brentuximab vedotin has been approved for treatment of certain diseases, but the purpose of the study is to see how well brentuximab vedotin, lenalidomide, and rituximab work together in treating diffuse large b-cell lymphoma and what side effects it causes.

You may be eligible for this study if: your diffuse large B-cell lymphoma has come back or did not get better with your last treatment.

There is a 50% chance you will receive lenalidomide, and rituximab with brentuximab and 50% chance of receiving lenalidomide, rituximab, and a placebo (inactive drug). We will take blood samples for safety and research tests and to check on your disease. You will also get blood drawn for your normal medical care. We will give you the study drugs in 21-day cycles. After you stop getting the study drugs, we will ask you to have follow-up visits or follow-up phone calls about every 3three months for a year. After a year, we will ask you to have follow-up visits or phone calls every 3- 6 months until the study is closed.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to your or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04404283