Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
ECHELON-3
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)
3 other identifiers
interventional
239
14 countries
145
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2020
Longer than P75 for phase_3
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedStudy Start
First participant enrolled
August 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 20, 2026
April 1, 2026
5.4 years
May 21, 2020
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
OS is defined as the time from the date of randomization to date of death due to any cause
Approximately 2 years
Secondary Outcomes (6)
Progression-free survival (PFS)
Approximately 1 year
Objective response rate (ORR)
Approximately 1 year
Complete response (CR) rate
Approximately 1 year
Duration of response (DOR)
Approximately 1 year
Incidence of adverse events
Approximately 1 year
- +1 more secondary outcomes
Study Arms (2)
Experimental Arm
EXPERIMENTALBrentuximab vedotin + lenalidomide + rituximab
Control Arm
ACTIVE COMPARATORPlacebo + lenalidomide + rituximab
Interventions
1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks
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.
Eligibility Criteria
You may qualify if:
- Participants with relapsed or refractory diffuse and transformed large B-cell lymphoma (R/R DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically determined by local pathology assessment for the purposes of study eligibility and stratification.
- Participants must have R/R disease following 2 or more lines of prior systemic therapy.
- For participants with transformed DLBCL, at least the last systemic therapy used must have been for DLBCL
- Participants must be HSCT or CAR-T ineligible according to the investigator and must meet at least one of the following criteria:
- One or more co-morbidities, including cardiac, pulmonary, renal or hepatic dysfunction that in the opinion of the Investigator make the participant medically unfit to received HSCT or CAR-T therapy
- Active disease following induction and salvage chemotherapy
- Inadequate stem cell mobilization (for HSCT)
- Relapse following prior HSCT or CAR-T
- Unable to receive CAR-T therapy due to financial, geographic, insurance, or manufacturing issues
- Participants must have tumor tissue submitted to the central pathology lab. The tumor tissue submitted should be from the most recent biopsy that contains DLBCL.
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Participants must have fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and bidimensional measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist within 28 days of Day 1.
You may not qualify if:
- History of another malignancy within 2 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy
- History of progressive multifocal leukoencephalopathy (PML)
- Active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months.
- Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted
- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
- Previous treatment with brentuximab vedotin or lenalidomide.
- Previous treatment with other vedotin-based ADCs is permitted if the last dose is at least 6 months prior to Day 1.
- Current therapy with immunosuppressive medications (including steroids), other systemic anti-neoplastic, or investigational agents
- a) Prednisone (or equivalent) ≤10 mg/day may be used for non-lymphomatous purposes
- Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to the first dose of study drugs
- Congestive heart failure, Class III or IV, by the NYHA criteria
- Grade 2 or higher peripheral sensory or motor neuropathy at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
Central Alabama Research
Birmingham, Alabama, 35209, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34211, United States
Florida Cancer Specialists
Cape Coral, Florida, 33909, United States
Florida Cancer Specialists
Daytona Beach, Florida, 32117, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Florida Cancer Specialists
Stuart, Florida, 34994, United States
Florida Cancer Specialists
Venice, Florida, 34285, United States
Florida Cancer Specialists
Venice, Florida, 34292, United States
Florida Cancer Specialists
Vero Beach, Florida, 32960, United States
Florida Cancer Specialists
Wellington, Florida, 33414, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
MidAmerica Division, Inc. c/o Menorah Medical Center
Overland Park, Kansas, 66209, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377, United States
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
MidAmerica Division, Inc. c/o Centerpoint Medical Center
Independence, Missouri, 64057, United States
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City, Missouri, 64132, United States
Barnes Jewish-Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center - North County
St Louis, Missouri, 63136, United States
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati, Ohio, 45211, United States
University of Cincinnati Medical Center IDS Pharmacy
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati, Ohio, 45236, United States
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati, Ohio, 45242, United States
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati, Ohio, 45245, United States
Oncology_Hematology Care Clinical Trials,LLC
Fairfield, Ohio, 45014, United States
West Chester Hospital
West Chester, Ohio, 45069, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29414, United States
Roper St. Francis Healthcare
Mt. Pleasant, South Carolina, 29464, United States
Roper St. Francis Healthcare
North Charleston, South Carolina, 29406, United States
US Oncology Investigational Products Center
Irving, Texas, 75063, United States
University of Virginia Cancer Center.
Charlottesville, Virginia, 22903, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Central Coast Local Health District, Gosford Hospital
Gosford, New South Wales, 2250, Australia
Central Coast Local Health District Wyong Hospital
Hamlyn Terrace, New South Wales, 2259, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Breakthrough Haematology Hollywood Specialist Centre
Nedlands, Western Australia, 6009, Australia
Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
Royal Adelaide Hospital
Adelaide, 5000, Australia
Bellberry Limited
Eastwood, Australia
Ramsay National Research Unit and Research Governance Office
Greenslopes, Australia
Tasmania Health and Medical HREC
Hobart, Australia
Hollywood Haematology
Nedlands, 6009, Australia
CHU UCL Namur-
Yvoir, Namur, 5530, Belgium
ZNA Middelheim
Antwerp, 2020, Belgium
ZNA Cadix
Antwerp, 2030, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Chu Helora
Haine-Saint-Paul, 7100, Belgium
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
CISSS de la Monteregie-Centre
Greenfield Park, Quebec, J4V 2H1, Canada
Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
Montreal, Quebec, H1T 2M4, Canada
Centre Integre Universitaire De Sante et de Services Sociaux Du Nord-de-I'ile-de-Montreal
Montreal, Quebec, H4J 1C5, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Clinical Trial Unit 2081
Copenhagen, 2100, Denmark
Zealand University Hospital Roskilde
Roskilde, 4000, Denmark
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie
Bordeaux, Other, 33000, France
Centre Hospitalier(CH) de Perpignan
Perpignan, Other, 66000, France
Hôpital Lyon Sud
Pierre-Bénite, Other, 69310, France
CHU Angers - Hotel Dieu Nord, Service des Maladies du Sang
Angers, 49933 Cedex 9, France
Centre Hospitalier Metropole Savoie
Chambéry, 73000, France
Centre Hospitalier Sud Francilien (CHSF)
Corbeil-Essonnes, 91106 cedex, France
CHU Grenoble Alpes
Grenoble, 38043 Cedex 9, France
Centre Hospitalier Le Mans
Le Mans, 72000, France
Service d'Hematologie Clinique
Limoges, 87042, France
Centre Hospitalier Regional Metz-Thionville Hopital Mercy Service d'hematologie
Metz, 57085, France
Centre Hospitalier Universitaire Nantes-Hotel Dieu, Service d'Hematologie
Nantes, Cedex 144093, France
Centre Antoine Lacassagne
Nice, 06189 Cedex 2, France
Hopital Saint-Antoine -
Paris, 75012, France
Service d'Hematologie clinique et Therapie cellulaire CHU Bordeaux Hopital Haut-Leveque
Pessac, 33600, France
Centre Henri Becquerel
Rouen, 76038, France
CHRU Hopital de Tours
Tours, 37000, France
CHRU de Nancy - Hopitaux de Brabois, Service Hematologie et Medecine interne
Vandœuvre-lès-Nancy, Cedex 54511, France
Institut Gustave Roussy Département d'Innovations Thérapeutiques et d'Essais Précoces (DITEP)
Villejuif, 94805 Cedex, France
IRCCS Istituto Tumori Giovanni Paolo II U.O. Ematologia
Bari, Apulia, 70124, Italy
Azienda Ospedaliera "Cardinale Giovanni Panico", U.O.C. Ematologia e Trapianti Midollo Osseo
Tricase, Lecce, 73039, Italy
Istituto Europeo di Oncologia
Milan, MI, 20141, Italy
Azienda Ospedaliero-Universitaria di Bologna - IRCCS
Bologna, Other, 40138, Italy
Ospedale Maggiore ASUGI
Trieste, 34125, Italy
Pratia MCM Krakow
Krakow, 30-510, Poland
Nasz Lekarz Osrodek Badan Klinicznych
Torun, 87-100, Poland
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
The Catholic University of Korea
Suwon, Gyeonggi-do, 16247, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Dong-A University Hospital.
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
SoonChunHyang University Hospital Seoul
Seoul, 04401, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul Saint Mary's Hospital
Seoul, 06591, South Korea
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Hospital San Pedro de Alcantara
Cáceres, Extremadura, 10003, Spain
Hospital Universitario QuironSalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Costa del Sol
Marbella, Malaga, 29603, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Hospital del Mar
Barcelona, Other, 08003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08029, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital San Pedro de Alcantara
Cáceres, 10005, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28080, Spain
Hospital Universitario QuironSalud Madrid
Pozuelo de Alarcon (madrid), 28223, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Kantonsspital Winterthur, Medizinische Onkologie
Winterthur, Canton of Zurich, 8401, Switzerland
Universitatsspital Zurich
Zurich, Other, 8091, Switzerland
Universitatsspital Basel
Basel, 4031, Switzerland
National Taiwan University Hospital Clinical Trial Pharmacy
Taipei, R.o.c, 100, Taiwan
National Taiwan University Hospital
Taipei, R.o.c, 100, Taiwan
Chang Gung Medical Foundation
Kaohsiung City, 833, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Hospital, Liouying
Tainan, 73657, Taiwan
Chi Mei Medical Center, Liouying
Tainan, 736, Taiwan
Pharmacy Department, Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
University Hospitals Birmingham NHS Foundation Trust
Birmingham, WEST Midlands, B15 2TH, United Kingdom
St Bartholomew's hospital
London, EC1A 7BE, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust
Sandwich, CT13 9ND, United Kingdom
Related Publications (2)
Bartlett NL, Hahn U, Kim WS, Fleury I, Laribi K, Bergua JM, Bouabdallah K, Forward N, Bijou F, MacDonald D, Portell CA, Ghesquieres H, Nowakowski G, Yasenchak CA, Patterson M, Ho L, Rustia E, Fanale M, Jie F, Kim JA. Brentuximab Vedotin Combination for Relapsed Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2025 Mar 20;43(9):1061-1072. doi: 10.1200/JCO-24-02242. Epub 2025 Jan 7.
PMID: 39772655DERIVEDWard JP, Berrien-Elliott MM, Gomez F, Luo J, Becker-Hapak M, Cashen AF, Wagner-Johnston ND, Maddocks K, Mosior M, Foster M, Krysiak K, Schmidt A, Skidmore ZL, Desai S, Watkins MP, Fischer A, Griffith M, Griffith OL, Fehniger TA, Bartlett NL. Phase 1/dose expansion trial of brentuximab vedotin and lenalidomide in relapsed or refractory diffuse large B-cell lymphoma. Blood. 2022 Mar 31;139(13):1999-2010. doi: 10.1182/blood.2021011894.
PMID: 34780623DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2020
First Posted
May 27, 2020
Study Start
August 20, 2020
Primary Completion
January 12, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.