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)

Who is this study for? Adult patients with diffuse large B-cell lymphoma
What treatments are being studied? Brentuximab vedotin
Status: Active_not_recruiting
Location: See all (183) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Central Alabama Research
Birmingham
California
University of California Davis Comprehensive Cancer Center
Sacramento
University of California Davis Medical Center
Sacramento
Florida
Florida Cancer Specialists
Bonita Springs
Florida Cancer Specialists
Bradenton
Florida Cancer Specialists
Cape Coral
Florida Cancer Specialists
Daytona Beach
Florida Cancer Specialists
Fort Myers
Florida Cancer Specialists
Fort Myers
Florida Cancer Specialists
Naples
Florida Cancer Specialists
Port Charlotte
Florida Cancer Specialists
Sarasota
Florida Cancer Specialists
Sarasota
Florida Cancer Specialists
Stuart
Florida Cancer Specialists
Venice
Florida Cancer Specialists
Venice
Florida Cancer Specialists
Vero Beach
Florida Cancer Specialists
Wellington
Florida Cancer Specialists
West Palm Beach
Kansas
MidAmerica Division, Inc. c/o Menorah Medical Center
Overland Park
Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore
Michigan
Henry Ford Hospital
Detroit
IP ADDRESS: Brigitte Harris Cancer Pavilion (BHCP)
Detroit
Karmanos Cancer Institute
Detroit
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills
Henry Ford Medical Center - Columbus
Novi
Missouri
Siteman Cancer Center - St. Peters
City Of Saint Peters
Siteman Cancer Center - West County
Creve Coeur
MidAmerica Division, Inc. c/o Centerpoint Medical Center
Independence
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City
Barnes Jewish-Hospital
St Louis
Siteman Cancer Center - North County
St Louis
Siteman Cancer Center - South County
St Louis
Washington University School of Medicine - Siteman Cancer Center
St Louis
Ohio
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati
Oncology_Hematology Care Clinical Trials,LLC
Cincinnati
University of Cincinnati Medical Center
Cincinnati
University of Cincinnati Medical Center IDS Pharmacy
Cincinnati
Oncology_Hematology Care Clinical Trials,LLC
Fairfield
West Chester Hospital
West Chester
Oregon
Oncology Associates of Oregon, P.C.
Eugene
Willamette Valley Cancer Institute and Research Center
Eugene
South Carolina
Roper St. Francis Healthcare
Charleston
Roper St. Francis Healthcare
Mt. Pleasant
Roper St. Francis Healthcare
North Charleston
Texas
US Oncology Investigational Product Center (IPC)
Irving
US Oncology Investigational Products Center
Irving
Virginia
University of Virginia Cancer Center.
Charlottesville
University of Virginia Health System
Charlottesville
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Bellberry Limited
Eastwood
Central Coast Local Health District, Gosford Hospital
Gosford
Ramsay National Research Unit and Research Governance Office
Greenslopes
Central Coast Local Health District Wyong Hospital
Hamlyn Terrace
Royal Hobart Hospital
Hobart
Tasmania Health and Medical HREC
Hobart
Breakthrough Haematology Hollywood Specialist Centre
Nedlands
Hollywood Haematology
Nedlands
Hollywood Private Hospital
Nedlands
Belgium
ZNA Cadix
Antwerp
ZNA Middelheim
Antwerp
Universitair Ziekenhuis Antwerpen
Edegem
Universitair Ziekenhuis Gent
Ghent
Universitair Ziekenhuis Gent
Ghent
CHU HELORA Hopital de Jolimont Pharmacie
Haine-saint-paul
CHU UCL Namur
Yvoir
Canada
CISSS de la Monteregie-Centre
Greenfield Park
Queen Elizabeth II Health Science Centre
Halifax
London Health Sciences Centre
London
Centre Integre Universitaire De Sante et de Services Sociaux Du Nord-de-I'ile-de-Montreal
Montreal
Centre Integre Universitaire de Sante et Services Sociaux de L'Est de l'lle de Montreal / installati
Montreal
The Ottawa Hospital - General Campus
Ottawa
Eastern Regional Health Authority
St. John's
Denmark
Aalborg University Hospital
Aalborg
Region Nordjylland, Produktion Faelles/kliniske Forsoeg
Aalborg
Hospitalsapoteket Region Midtjylland
Aarhus C
Aarhus University Hospital
Aarhus N
Clinical Trial Unit 2081
Copenhagen
Nuklearmedicin
Copenhagen
Zealand University Hospital Roskilde
Roskilde
France
CHU Angers - Hotel Dieu Nord, Service des Maladies du Sang
Angers
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie
Bordeaux
Centre de Lutte Contre le Cancer (CLCC) - lnstitut Bergonie Pharmacie
Bordeaux
Centre Hospitalier Metropole Savoie
Chambéry
Centre Hospitalier Sud Francilien (CHSF)
Corbeil-essonnes
CHU Grenoble Alpes
Grenoble
Centre Hospitalier Le Mans
Le Mans
Pharmacie a Usage lnterieur CHU de LIMOGES
Limoges
Service d'Hematologie Clinique
Limoges
CHR Metz-Thionville Hopital Mercy
Metz
Centre Hospitalier Universitaire Nantes-Hotel Dieu, Service d'Hematologie
Nantes
CHU de NANTES Hotel-Dieu Pharmacie - PTMC Rez de Jardin - Essais cliniques UPCO
Nantes
Centre Antoine Lacassagne
Nice
Hopital Saint-Antoine -
Paris
Centre Hospitalier(CH) de Perpignan
Perpignan
Service Pharmacie Essais Cliniques Centre Hospitalier (CH) de Perpignan
Perpignan
Pharmacie Hopital Haut-Leveque Unite des Essais Cliniques
Pessac
Service d'Hematologie clinique et Therapie cellulaire CHU Bordeaux Hopital Haut-Leveque
Pessac
Hôpital Lyon Sud
Pierre-bénite
Hôpital Lyon Sud
Pierre-bénite
Centre Henri Becquerel - Service Pharmacie
Rouen
Centre Henri Becquerel Service d'Hematologie
Rouen
Service de Radiologie ,Centre Henri Becquerel
Rouen
CHRU Hopital de Tours
Tours
CHRU de Nancy - Hopitaux de Brabois, Service Hematologie et Medecine interne
Vandœuvre-lès-nancy
Pharmacie Brabois - Secteur Essais Cliniques 5
Vandœuvre-lès-nancy
Institut Gustave Roussy Département d'Innovations Thérapeutiques et d'Essais Précoces (DITEP)
Villejuif
Institut Gustave Roussy Département Pharmacie
Villejuif
Ireland
ICON Laboratory Services
Leopardstown
Italy
IRCCS Istituto Tumori Giovanni Paolo II U.O. Ematologia
Bari
Azienda Ospedaliero-Universitaria di Bologna - IRCCS
Bologna
Istituto Europeo di Oncologia
Milan
Azienda Ospedaliera Cardinale Giovanni Panico, U.O.C. Ematologia e Trapianti Midollo Osseo
Tricase
Farmacia Ospedaliera Azienda Ospedaliera Cardinale Giovanni Panico
Tricase
Ospedale Maggiore ASUGI
Trieste
Poland
Pratia MCM Krakow
Krakow
Voxel S.A.
Krakow
Zaklad Rentgena i Usg - Wyrobek Sp. z o.o. sp. k
Krakow
Zaklad Rentgena i Usg - Wyrobek Sp. z o.o. sp. k
Krakow
Nasz Lekarz Osrodek Badan Klinicznych
Torun
Republic of Korea
Dong-A University Hospital.
Busan
Inje University Busan Paik Hospital
Busan
Pusan National University Hospital
Busan
Keimyung University Dongsan Hospital
Daegu
National Cancer Center
Goyang-si
Gachon University Gil Medical Center
Incheon
Jeonbuk National University Hospital
Jeonju
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Severance Hospital Yonsei University Health System
Seoul
SoonChunHyang University Hospital Seoul
Seoul
The Catholic University of Korea, Seoul Saint Mary's Hospital
Seoul
The Catholic University of Korea
Suwon
Spain
Hospital Universitario de Badajoz
Badajoz
Assaigs Clfnics-Servei de Farmacia
Barcelona
CETIR
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital de la Santa Creu i Sant Pau- Pharmacy
Barcelona
Hospital del Mar
Barcelona
Hospital Quiron
Barcelona
Hospital Quironsalud Barcelona
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Institute Catala d'Oncologia_Hospital Duran i Reynals
Barcelona
Hospital San Pedro de Alcantara
Cáceres
Hospital San Pedro de Alcantara
Cáceres
Hospital La Milagrosa
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario La Paz
Madrid
FUNDAClON GENERAL UNIVERSIDAD DE MALAGA (FGUMA)
Málaga
Hospital Costa Del Sol
Marbella
Hospital Rey Juan Carlos
Móstoles
Clinica Universidad de Navarra
Pamplona
Complejo Hospitalario de Navarra
Pamplona
Hospital de Navarra
Pamplona
Hospital Universitario QuironSalud Madrid
Pozuelo De Alarcón
Hospital Universitario Quironsalud Madrid - Pharmacy
Pozuelo De Alarcon (madrid )
Hospital Universitario QuironSalud Madrid
Pozuelo De Alarcon (madrid)
Centro de Diagnostico y Resonancia Magnetica
Salamanca
Hospital Clinico Universitario de Salamanca
Salamanca
Hospital Clínico Universitario de Salamanca
Salamanca
Switzerland
Universitatsspital Basel
Basel
Kantonsapotheke Zurich
Schlieren
Kantonsspital Winterthur, Medizinische Onkologie
Winterthur
KS Winterthur Kantonsspitalapotheke
Winterthur
Universitatsspital Zurich
Zurich
Taiwan
Chang Gung Medical Foundation
Kaohsiung City
Chi Mei Hospital, Liouying
Tainan City
Chi Mei Medical Center, Liouying
Tainan City
National Cheng Kung University Hospital
Tainan City
National Taiwan University Hospital
Taipei
National Taiwan University Hospital Clinical Trial Pharmacy
Taipei
Pharmacy Department, Taipei Veterans General Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan District
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Chemotherapy Production Unit (CPU)
London
Dispensary Oral Drugs
London
Guy's and St Thomas' NHS Foundation Trust
London
St Bartholomew's hospital
London
Time Frame
Start Date: 2020-08-20
Completion Date: 2025-11-18
Participants
Target number of participants: 239
Treatments
Experimental: Experimental Arm
Brentuximab vedotin + lenalidomide + rituximab
Active_comparator: Control Arm
Placebo + lenalidomide + rituximab
Authors
Anna Cowley, Irl Brian Greenwell, Michael S Roberts, Khaleel Ashraf, Deborah Katz, Craig Portell, Tahir Latif, Grzegorz S Nowakowski, Howland Crosswell, Benjamin Freeman, William Harwin, Seung T Lee, Elizabeth Cull, Zulfiqar Malik, Mhd Nabeel Rajeh, Leonard Klein, Guillermo Abesada-Terk, Joseph Tuscano, Priyanka Pophali, David MacDonald, Erlene Seymour, Dahlia Sano, David Cosgrove, Miguel Angel Canales, Radhakrishnan Ramchandren, Tulin Budak-Alpdogan, Robert G Bociek, Mark J Fesler, Robert D Siegel, James Orcutt, Neal Manning, Sarah Tomassetti, John S Renshaw, Vijay Patel, Sherjeel Sana, Katisha Vance, Nancy Bartlett, Christopher Yasenchak, Lysiane Molina, Fontanet Bijou, Gian Pica, Laure Lebras, Thomas Gastinne, Steven Le Gouill, Kamal Krimo Bouabdallah, Fritz Offner, Stephane Vigouroux, Pierre Feugier, Isabelle Fleury, Frederic Peyrade, Herve Ghesquieres, Ludovic Fouillet, Marc Andre, Denis Guyotat, Adrian Tempescul, Kamel Laribi, John Gribben, Julie Abraham, Jerome Paillassa, Bernard Drenou, Bertrand Joly, Vincent Camus, Dipenkumar Modi, Suman Kambhampati, Daniel Lebovic, Miguel A Islas-Ohlmayer, Cheolwon Suh, Ho-Sup Lee, Alberto Bosi, Remy Dulery, Hao-Yuan Wang, Natalie Fischer, Jae-Yong Kwak, Pierre Desjardins, Mary Gleeson, Tycho Stephan Baumann, Young Rok Do, Jose A Hernandez, Judit Meszaros Joergensen, Angel Ramírez Payer, Tai-Chung Huang, Su-Peng Yeh, Sheng-Yen Hsiao, Paw Jensen, Nicholas Murphy, Uwe Hahn, Mathilde Hunault, Jose Maria Arguinano, Juan Miguel Bergua, Anne Ortved Gang, Wojciech Jurczak, Sebastian Grosicki, Thorsten Zenz, Christian Bjorn Poulsen, Alejandro Martin Garcia-Sancho, Benedetta Puccini, Ho-Jin Shin, Corrado Tarella, Attilio Guarini, Pier Luigi Zinzani, Ho-Young Yhim, Frank Stenner, Olivier Casasnovas, David Belada, Heidi Mocikova, Juan-Manuel Sancho, Leonardo Flenghi, Jong-Ho Won, Sung Yong Oh, Selay Lam, Dries Deeren, Hyungwoo Cho, Francesco Zaja, Won Seog Kim
Sponsors
Leads: Seagen, a wholly owned subsidiary of Pfizer

This content was sourced from clinicaltrials.gov

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