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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04404283

Public ClinicalTrials.gov record NCT04404283. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 5:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT04404283
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
239 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 20, 2020 (Actual)
Primary completion
Jan 23, 2026 (Actual)
Completion
Dec 31, 2026 (Estimated)
Last update posted
Jul 22, 2026

2020 – 2026

United States locations

U.S. sites
47
U.S. states
12
U.S. cities
34
Facility City State ZIP Site status
Central Alabama Research Birmingham Alabama 35209 —
University of California Davis Comprehensive Cancer Center Sacramento California 95817 —
University of California Davis Medical Center Sacramento California 95817 —
Florida Cancer Specialists Bonita Springs Florida 34135 —
Florida Cancer Specialists Bradenton Florida 34211 —
Florida Cancer Specialists Cape Coral Florida 33909 —
Florida Cancer Specialists Daytona Beach Florida 32117 —
Florida Cancer Specialists Fort Myers Florida 33905 —
Florida Cancer Specialists Fort Myers Florida 33908 —
Florida Cancer Specialists Naples Florida 34102 —
Florida Cancer Specialists Port Charlotte Florida 33980 —
Florida Cancer Specialists Sarasota Florida 34232 —
Florida Cancer Specialists Sarasota Florida 34236 —
Florida Cancer Specialists Stuart Florida 34994 —
Florida Cancer Specialists Venice Florida 34285 —
Florida Cancer Specialists Venice Florida 34292 —
Florida Cancer Specialists Vero Beach Florida 32960 —
Florida Cancer Specialists Wellington Florida 33414 —
Florida Cancer Specialists West Palm Beach Florida 33401 —
MidAmerica Division, Inc. c/o Menorah Medical Center Overland Park Kansas 66209 —
University of Maryland, Greenebaum Comprehensive Cancer Center Baltimore Maryland 21201 —
Karmanos Cancer Institute Detroit Michigan 48201 —
Henry Ford Hospital Detroit Michigan 48202 —
Karmanos Cancer Institute Weisberg Cancer Treatment Center Farmington Hills Michigan 48334 —
Henry Ford Medical Center - Columbus Novi Michigan 48377 —
Siteman Cancer Center - St. Peters City of Saint Peters Missouri 63376 —
Siteman Cancer Center - West County Creve Coeur Missouri 63141 —
MidAmerica Division, Inc. c/o Centerpoint Medical Center Independence Missouri 64057 —
MidAmerica Division, Inc., c/o Research Medical Center Kansas City Missouri 64132 —
Barnes Jewish-Hospital St Louis Missouri 63110 —
Washington University School of Medicine - Siteman Cancer Center St Louis Missouri 63110 —
Siteman Cancer Center - South County St Louis Missouri 63129 —
Siteman Cancer Center - North County St Louis Missouri 63136 —
Oncology_Hematology Care Clinical Trials,LLC Cincinnati Ohio 45211 —
University of Cincinnati Medical Center Cincinnati Ohio 45219 —
Oncology_Hematology Care Clinical Trials,LLC Cincinnati Ohio 45236 —
Oncology_Hematology Care Clinical Trials,LLC Cincinnati Ohio 45242 —
Oncology_Hematology Care Clinical Trials,LLC Cincinnati Ohio 45245 —
Oncology_Hematology Care Clinical Trials,LLC Fairfield Ohio 45014 —
West Chester Hospital West Chester Ohio 45069 —
Oncology Associates of Oregon, P.C. Eugene Oregon 97401 —
Roper St. Francis Healthcare Charleston South Carolina 29414 —
Roper St. Francis Healthcare Mt. Pleasant South Carolina 29464 —
Roper St. Francis Healthcare North Charleston South Carolina 29406 —
US Oncology Investigational Products Center Irving Texas 75063 —
University of Virginia Cancer Center. Charlottesville Virginia 22903 —
University of Virginia Health System Charlottesville Virginia 22908 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 96 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04404283, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 22, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04404283 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →