Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL (ECHELON-3)
Diffuse Large B-cell Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Central Alabama ResearchRecruiting
- Alabama Oncology
- Arizona Oncology Associates, PC - NAHOA
- The Oncology Institute of Hope & Innovation - California
- University of California Davis
- Lundquist Institute/Harbor-UCLA
- Florida Cancer Specialists - South Region
- Florida Cancer Specialists - North Region
- Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
- Rush University Medical Center
- Illinois Cancer Specialists
- University of Maryland
- Karmanos Cancer Institute / Wayne State University
- Henry Ford Health System
- Cancer and Hematology Centers of Western Michigan / Lemmen-Holton Cancer Pavilion
- Ascension St John Hospital
- Mayo Clinic Rochester
- HCA Midwest Health Kansas City
- Saint Louis University
- Washington University in St LouisRecruiting
- University of Nebraska Medical Center
- MD Anderson Cancer Center at Cooper Health
- Summit Medical Group
- New York Cancer and Blood Specialists
- Oncology Hematology CareRecruiting
- University of Cincinnati Cancer Institute
- Willamette Valley Cancer Institute and Research CenterRecruiting
- Roper St. Francis HealthcareRecruiting
- Medical University of South Carolina/Hollings Cancer Center
- Saint Francis Hospital / Bon Secours - South Carolina
- Prisma Health
- University of Tennessee
- Texas Oncology - Austin Midtown
- Texas Oncology - San Antonio Medical Center
- University of VirginiaRecruiting
- Northwest Cancer Specialists, P.C.
- Carbone Cancer Center / University of Wisconsin
- Aurora Health Care, Inc
- Royal Adelaide HospitalRecruiting
- Central Coast Local Health District (Gosford and Wyong Hospitals)Recruiting
- Royal Hobart HospitalRecruiting
- Hollywood HaematologyRecruiting
- Royal North Shore HospitalRecruiting
- Ziekenhuis Netwerk Antwerpen Campus StuivenbergRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- Universitair Ziekenhuis GentRecruiting
- Hopital de JolimontRecruiting
- Clinique Saint PierreRecruiting
- AZ Delta - Campus WilgenstraatRecruiting
- CHU UCL NamurRecruiting
- H. Bliss Murphy Cancer Centre / Eastern Regional Health AuthorityRecruiting
- Queen Elizabeth II Health Sciences CentreRecruiting
- William Osler Health SciencesRecruiting
- London Health Sciences Centre - Victoria HospitalRecruiting
- Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC)Recruiting
- University of Ottawa / Ottawa General HospitalRecruiting
- CISSS de la Monteregie-CentreRecruiting
- CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-RosemontRecruiting
- CIUSS NIM/Hopital du Sacre-Coeur de MontrealRecruiting
- Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologieRecruiting
- Fakultni Nemocnice Kralovske VinohradyRecruiting
- Vseobecna fakultni nemocnice v PrazeRecruiting
- Aalborg Universitetshospital
- Aarhus University HospitalRecruiting
- RigshospitaletRecruiting
- Zealand University Hospital (Roskilde Sygehus)Recruiting
- Center Hospitalier Universitaire d' AngersRecruiting
- Centre de Lutte Contre le Cancer (CLCC) - Institut BergonieRecruiting
- Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan
- CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies
- Centre Hospitalier Metropole Savoie - ChamberyRecruiting
- Centre Hospitalier Sud FrancilienRecruiting
- Centre Hospitalier Universitaire (CHU) Dijon BourgogneRecruiting
- Centre Hospitalier Universitaire de GrenobleRecruiting
- Centre Hospitalier Le MansRecruiting
- Centre Hospitalier Universitaire (CHU) De Limoges - Hopital DupuytrenRecruiting
- Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-AlpesRecruiting
- Centre Hospitalier Regional Metz-Thionville, Hopital MercyRecruiting
- Hopital Emile Muller
- Centre Hospitalier Universitaire Nantes-Hotel Dieu
- Centre de Lutte contre le Cancer (CLCC) - Centre Antoine LacassagneRecruiting
- Centre Hospitalier de PerpignanRecruiting
- CHU Bordeaux Hopital Haut-LevequeRecruiting
- Centre Hospitalier Lyon SudRecruiting
- Centre Henri Becquerel / Centre Regional de Lutte Contre le CancerRecruiting
- Institut de Cancerologie Hematologie Universitaire de Saint Etienne (I.CHU.SE)Recruiting
- Centre Hospitalier Universitaire de Nancy - Hopital de BraboisRecruiting
- Institut Gustave RoussyRecruiting
- CHU Tours - Hopital BretonneauRecruiting
- Hopital Saint-AntoineRecruiting
- Medizinische Klinik & Poliklinik III (Bonn)nUniversitätsklinikum Bonn
- Stadtisches Klinikum Brandenburg GmbH
- Universitaetsklinikum Dusseldorf
- Universitaetsklinikum Halle (Saale)
- Centro di Riferimento Oncologico di AvianoRecruiting
- IRCCS Istituto Tumori Giovanni Paolo IIRecruiting
- Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-MalpighiRecruiting
- Azienda Ospedaliero Universitaria Careggi
- Azienda Ospedaliera Universitaria San MartinoRecruiting
- Azienda Ospedaliera Cardinale Giovanni PanicoRecruiting
- IRCCS Ospedale San RaffaeleRecruiting
- Istituto Europeo di OncologiaRecruiting
- Azienda Ospedaliera Universitaria (AOU) Federico IIRecruiting
- AOOR Villa Sofia Cervello - Presidio V. CervelloRecruiting
- Azienda Ospedaliero Universitaria di ParmaRecruiting
- IRCSS Policlinico San MatteoRecruiting
- Universita degli Studi di Perugia Azienda Ospedaliera di Perugia (Ospedale Santa Maria della Misericordia)Recruiting
- UO Ematologia RavennaRecruiting
- AUSL della Romagna Ospedale InfermiRecruiting
- Policlinico Universitario Agostino GemelliRecruiting
- IRCCS Ospedale Casa Sollievo della SofferenzaRecruiting
- Azienda Sanitaria Universitaria Giuliano IsontinaRecruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
- Dong-A University HospitalRecruiting
- Pusan National University Hospital
- Kosin University Gospel Hospital
- Inje University Busan-Paik HospitalRecruiting
- Keimyung University Dongsan Medical CenterRecruiting
- National Cancer CenterRecruiting
- Gachon University Gil Medical CenterRecruiting
- Jeonbuk National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Soon Chun Hyang University Hospital SeoulRecruiting
- Asan Medical Center - OncologyRecruiting
- Samsung Medical Center
- Seoul Saint Mary's HospitalRecruiting
- St. Vincent's Hospital, The Catholic University of KoreaRecruiting
- Slingeland ziekenhuisRecruiting
- Pratia Onkologia Katowice
- Pratia MCM KrakowRecruiting
- Warmian-Masurian Cancer Center of The Ministry of The Interior and Administraton's HospitalRecruiting
- Pratia PoznanRecruiting
- Nasz Lekarz Osrodek Badan Klinicznych
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyRecruiting
- Hospital Universitari Germans Trias i PujolRecruiting
- Hospital del MarRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital San Pedro de AlcantaraRecruiting
- Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)Recruiting
- Clinica Universidad de NavarraRecruiting
- Hospital Universitario Infanta Leonor
- Hospital Puerta de Hierro MajadahondaRecruiting
- Hospital Universitario Fundacion Jimenez DiazRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Regional Universitario de Malaga - Hospital General
- Hospital Costa del SolRecruiting
- Hospital Universitario Central de AsturiasRecruiting
- Clinica Universidad de NavarraRecruiting
- Complejo Hospitalario de NavarraRecruiting
- Hospital Universitario Quironsalud MadridRecruiting
- Hospital Clínico Universitario de SalamancaRecruiting
- Universitatsspital BaselRecruiting
- Kantonsspital Winterthur (KSW)Recruiting
- Universitatsspital ZurichRecruiting
- Chang Gung Memorial Hospital - KaohsiungRecruiting
- China Medical University Hospital
- Chang Gung Memorial Hospital - TaoyuanRecruiting
- National Cheng-Kung University HospitalRecruiting
- Chi Mei Hospital Liouying
- National Taiwan University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- East Sussex Healthcare NHS Trust
- University Hospitals Birmingham NHS Foundation TrustRecruiting
- St Bartholomew's HospitalRecruiting
- Guy's and St Thomas' NHS FoundationRecruiting
- The Royal Marsden HospitalRecruiting
- Maidstone and Tunbridge Wells NHS TrustRecruiting
- The Royal Marsden Hospital (Surrey)Recruiting
- Singleton HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental Arm
Control Arm
Brentuximab vedotin + lenalidomide + rituximab
Placebo + lenalidomide + rituximab