Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Registration Number
- NCT04404283
- Lead Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 241
-
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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm Lenalidomide Brentuximab vedotin + lenalidomide + rituximab Control Arm Lenalidomide Placebo + lenalidomide + rituximab Control Arm Placebo Placebo + lenalidomide + rituximab Control Arm Rituximab Placebo + lenalidomide + rituximab Experimental Arm Brentuximab vedotin Brentuximab vedotin + lenalidomide + rituximab Experimental Arm Rituximab Brentuximab vedotin + lenalidomide + rituximab
- Primary Outcome Measures
Name Time Method Overall survival (OS) Approximately 2 years OS is defined as the time from the date of randomization to date of death due to any cause
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Approximately 1 year PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. Assessment of PD will be performed by the investigator based on the Lugano Criteria for Response Assessment (Cheson 2014)
Incidence of adverse events Approximately 1 year Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
OS in CD30+ participants Approximately 2 years Time from the date of randomization to date of death due to any cause.
Objective response rate (ORR) Approximately 1 year Proportion of participants with best response of complete response (CR) or partial response (PR) according to investigator assessment per the Lugano Criteria for Response Assessment (Cheson 2014).
Complete response (CR) rate Approximately 1 year Proportion of participants with best response of CR according to investigator assessment per the Lugano Criteria for Response Assessment (Cheson 2014)
Duration of response (DOR) Approximately 1 year Time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression by investigator assessment per the Lugano Criteria for Response Assessment (Cheson 2014) or death due to any cause, whichever occurs first.
Trial Locations
- Locations (171)
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Arizona Oncology Associates, PC - NAHOA
🇺🇸Goodyear, Arizona, United States
The Oncology Institute of Hope & Innovation - California
🇺🇸Riverside, California, United States
University of California Davis
🇺🇸Sacramento, California, United States
Lundquist Institute/Harbor-UCLA
🇺🇸Torrance, California, United States
Florida Cancer Specialists - South Region
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialists - North Region
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
🇺🇸West Palm Beach, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan / Lemmen-Holton Cancer Pavilion
🇺🇸Grand Rapids, Michigan, United States
Ascension St John Hospital
🇺🇸Grosse Pointe Woods, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
HCA Midwest Health Kansas City
🇺🇸Kansas City, Missouri, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Washington University in St Louis
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
MD Anderson Cancer Center at Cooper Health
🇺🇸Camden, New Jersey, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
New York Cancer and Blood Specialists
🇺🇸Shirley, New York, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Roper St. Francis Healthcare
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina/Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Saint Francis Hospital / Bon Secours - South Carolina
🇺🇸Greenville, South Carolina, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States
Texas Oncology - Austin Midtown
🇺🇸Austin, Texas, United States
Texas Oncology - San Antonio Medical Center
🇺🇸San Antonio, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Northwest Cancer Specialists, P.C.
🇺🇸Vancouver, Washington, United States
Carbone Cancer Center / University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Aurora Health Care, Inc
🇺🇸Wauwatosa, Wisconsin, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Other, Australia
Central Coast Local Health District (Gosford and Wyong Hospitals)
🇦🇺Gosford, Other, Australia
Royal Hobart Hospital
🇦🇺Hobart, Other, Australia
Hollywood Haematology
🇦🇺Nedlands, Other, Australia
Royal North Shore Hospital
🇦🇺Saint Leonards, Other, Australia
Ziekenhuis Netwerk Antwerpen Campus Stuivenberg
🇧🇪Antwerpen, Other, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Other, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Other, Belgium
CHU Helora Hopital de La Louviere Site Jolimont
🇧🇪Haine-Saint-Paul, Other, Belgium
Clinique Saint Pierre
🇧🇪Ottignies, Other, Belgium
AZ Delta - Campus Wilgenstraat
🇧🇪Roeselare, Other, Belgium
CHU UCL Namur
🇧🇪Yvoir, Other, Belgium
H. Bliss Murphy Cancer Centre / Eastern Regional Health Authority
🇨🇦St John's, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
William Osler Health Sciences
🇨🇦East Brampton, Ontario, Canada
London Health Sciences Centre - Victoria Hospital
🇨🇦London, Ontario, Canada
Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC)
🇨🇦Oshawa, Ontario, Canada
University of Ottawa / Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
CISSS de la Monteregie-Centre
🇨🇦Greenfield Park, Quebec, Canada
CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
CIUSS NIM/Hopital du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
🇨🇿Hradec Kralove, Other, Czechia
Fakultni Nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Other, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Other, Czechia
Aalborg Universitetshospital
🇩🇰Aalborg, Other, Denmark
Aarhus University Hospital
🇩🇰Aarhus N, Other, Denmark
Rigshospitalet
🇩🇰Copenhagen, Other, Denmark
Zealand University Hospital (Roskilde Sygehus)
🇩🇰Roskilde, Other, Denmark
Center Hospitalier Universitaire d' Angers
🇫🇷Angers Cedex 9, Other, France
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie
🇫🇷Bordeaux, Other, France
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan
🇫🇷Brest Cedex, Other, France
CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies
🇫🇷Cedex 9, Other, France
Centre Hospitalier Metropole Savoie - Chambery
🇫🇷Chambery, Other, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, Other, France
Centre Hospitalier Universitaire (CHU) Dijon Bourgogne
🇫🇷Dijon, Other, France
Centre Hospitalier Universitaire de Grenoble
🇫🇷Grenoble, Other, France
Centre Hospitalier Le Mans
🇫🇷Le Mans, Other, France
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
🇫🇷Limoges Cedex, Other, France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
🇫🇷Lyon, Other, France
Centre Hospitalier Regional Metz-Thionville, Hopital Mercy
🇫🇷Metz, Other, France
Hopital Emile Muller
🇫🇷Mulhouse, Other, France
Centre Hospitalier Universitaire Nantes-Hotel Dieu
🇫🇷Nantes cedex 1, Other, France
Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
🇫🇷Nice Cedex 2, Other, France
Centre Hospitalier de Perpignan
🇫🇷Perpignan CEDEX, Other, France
CHU Bordeaux Hopital Haut-Leveque
🇫🇷Pessac Cedex, Other, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Benite Cedex, Other, France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
🇫🇷Rouen, Other, France
Institut de Cancerologie Hematologie Universitaire de Saint Etienne (I.CHU.SE)
🇫🇷Saint Etienne Cedex 2, Other, France
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
🇫🇷Vandoeuvre-Les-Nancy Cedex 9, Other, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, Other, France
CHU Tours - Hopital Bretonneau
🇫🇷Paris, France
Hopital Saint-Antoine
🇫🇷Paris, France
Medizinische Klinik & Poliklinik III (Bonn)nUniversitätsklinikum Bonn
🇩🇪Bonn, Other, Germany
Stadtisches Klinikum Brandenburg GmbH
🇩🇪Brandenburg, Other, Germany
Universitaetsklinikum Dusseldorf
🇩🇪Duesseldorf, Other, Germany
Universitaetsklinikum Halle (Saale)
🇩🇪Halle (S.), Other, Germany
Centro di Riferimento Oncologico di Aviano
🇮🇹Aviano (Pordenone), Other, Italy
IRCCS Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Other, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Other, Italy
Azienda Ospedaliero Universitaria Careggi
🇮🇹Firenze, Other, Italy
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Other, Italy
Azienda Ospedaliera Cardinale Giovanni Panico
🇮🇹Lecce, Other, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Other, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Other, Italy
Azienda Ospedaliera Universitaria (AOU) Federico II
🇮🇹Napoli, Other, Italy
AOOR Villa Sofia Cervello - Presidio V. Cervello
🇮🇹Palermo, Other, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Other, Italy
IRCSS Policlinico San Matteo
🇮🇹Pavia, Other, Italy
Universita degli Studi di Perugia Azienda Ospedaliera di Perugia (Ospedale Santa Maria della Misericordia)
🇮🇹Perugia, Other, Italy
UO Ematologia Ravenna
🇮🇹Ravenna, Other, Italy
AUSL della Romagna Ospedale Infermi
🇮🇹Rimini, Other, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Other, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo (Foggia), Other, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
🇮🇹Trieste, Other, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Dong-A University Hospital
🇰🇷Busan, Other, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Other, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Other, Korea, Republic of
Inje University Busan-Paik Hospital
🇰🇷Busan, Other, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Other, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si, Other, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Other, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju-Si, Other, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Other, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Other, Korea, Republic of
Asan Medical Center - Oncology
🇰🇷Seoul, Other, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Other, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Other, Korea, Republic of
Seoul Saint Mary's Hospital
🇰🇷Seoul, Other, Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea
🇰🇷Suwon-si, Other, Korea, Republic of
Slingeland ziekenhuis
🇳🇱Doetinchem, Other, Netherlands
Pratia Onkologia Katowice
🇵🇱Katowice, Other, Poland
Pratia MCM Krakow
🇵🇱Krakow, Other, Poland
Warmian-Masurian Cancer Center of The Ministry of The Interior and Administraton's Hospital
🇵🇱Olsztyn, Other, Poland
Pratia Poznan
🇵🇱Skorzewo, Other, Poland
Nasz Lekarz Osrodek Badan Klinicznych
🇵🇱Torun, Other, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
🇵🇱Warsaw, Other, Poland
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Other, Spain
Hospital del Mar
🇪🇸Barcelona, Other, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Other, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Other, Spain
Hospital San Pedro de Alcantara
🇪🇸Caceres, Other, Spain
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
🇪🇸L'Hospitalet de Llobregat, Other, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Other, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Other, Spain
Hospital Puerta de Hierro Majadahonda
🇪🇸Madrid, Other, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Other, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Other, Spain
Hospital Regional Universitario de Malaga - Hospital General
🇪🇸Malaga, Other, Spain
Hospital Costa del Sol
🇪🇸Marbella, Other, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Other, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Other, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Other, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Other, Spain
Universitatsspital Basel
🇨🇭Basel, Other, Switzerland
Kantonsspital Winterthur (KSW)
🇨🇭Winterthur, Other, Switzerland
Universitatsspital Zurich
🇨🇭Zurich, Other, Switzerland
Chang Gung Memorial Hospital - Kaohsiung
🇨🇳Kaohsiung, Other, Taiwan
China Medical University Hospital
🇨🇳Taichung, Other, Taiwan
Chang Gung Memorial Hospital - Taoyuan
🇨🇳Tainan, Other, Taiwan
National Cheng-Kung University Hospital
🇨🇳Tainan, Other, Taiwan
Chi Mei Hospital Liouying
🇨🇳Tainan, Other, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Other, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Other, Taiwan
East Sussex Healthcare NHS Trust
🇬🇧Eastbourne, Other, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Edgbaston, Birmingham, Other, United Kingdom
St Bartholomew's Hospital
🇬🇧London, Other, United Kingdom
Guy's and St Thomas' NHS Foundation
🇬🇧London, Other, United Kingdom
The Royal Marsden Hospital
🇬🇧London, Other, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
🇬🇧Maidstone, Other, United Kingdom
The Royal Marsden Hospital (Surrey)
🇬🇧Sutton, Other, United Kingdom
Singleton Hospital
🇬🇧Swansea, Other, United Kingdom