Diffuse Large B-cell LymphomaPhase 3ECHELON-3NCT04404283
Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
A Phase 3 study testing Brentuximab vedotin, Rituximab and Lenalidomide in people with Diffuse Large B-cell Lymphoma, run by Seagen, a wholly owned subsidiary of Pfizer at 143 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Brentuximab vedotin, Rituximab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 143 sitesin 14 countries
- Study dates
- 20 Aug 2020to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
- 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
Trial locations and contacts
143 sites in 14 countries.
143 sites in 14 countries
United States47 sites
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Central Alabama Research
Birmingham, Alabama, 35209
Florida Cancer Specialists
Bonita Springs, Florida, 34135
Florida Cancer Specialists
Bradenton, Florida, 34211
Florida Cancer Specialists
Cape Coral, Florida, 33909
Roper St. Francis Healthcare
Charleston, South Carolina, 29414
University of Virginia Cancer Center.
Charlottesville, Virginia, 22903
University of Virginia Health System
Charlottesville, Virginia, 22908
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
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
Florida Cancer Specialists
Daytona Beach, Florida, 32117
Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
Oncology_Hematology Care Clinical Trials,LLC
Fairfield, Ohio, 45014
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Florida Cancer Specialists
Fort Myers, Florida, 33905
Florida Cancer Specialists
Fort Myers, Florida, 33908
MidAmerica Division, Inc. c/o Centerpoint Medical Center
Independence, Missouri, 64057
US Oncology Investigational Products Center
Irving, Texas, 75063
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City, Missouri, 64132
Roper St. Francis Healthcare
Mt. Pleasant, South Carolina, 29464
Florida Cancer Specialists
Naples, Florida, 34102
Roper St. Francis Healthcare
North Charleston, South Carolina, 29406
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
MidAmerica Division, Inc. c/o Menorah Medical Center
Overland Park, Kansas, 66209
Florida Cancer Specialists
Port Charlotte, Florida, 33980
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
University of California Davis Medical Center
Sacramento, California, 95817
Florida Cancer Specialists
Sarasota, Florida, 34232
Florida Cancer Specialists
Sarasota, Florida, 34236
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
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
West Chester Hospital
West Chester, Ohio, 45069
Florida Cancer Specialists
West Palm Beach, Florida, 33401
France18 sites
CHU Angers - Hotel Dieu Nord, Service des Maladies du Sang
Angers, 49933 Cedex 9
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie
Bordeaux, Other, 33000
Centre Hospitalier Metropole Savoie
Chambéry, 73000
Centre Hospitalier Sud Francilien (CHSF)
Corbeil-Essonnes, 91106 cedex
CHU Grenoble Alpes
Grenoble, 38043 Cedex 9
Centre Hospitalier Le Mans
Le Mans, 72000
Service d'Hematologie Clinique
Limoges, 87042
Centre Hospitalier Regional Metz-Thionville Hopital Mercy Service d'hematologie
Metz, 57085
Centre Hospitalier Universitaire Nantes-Hotel Dieu, Service d'Hematologie
Nantes, Cedex 144093
Centre Antoine Lacassagne
Nice, 06189 Cedex 2
Hopital Saint-Antoine -
Paris, 75012
Centre Hospitalier(CH) de Perpignan
Perpignan, Other, 66000
Service d'Hematologie clinique et Therapie cellulaire CHU Bordeaux Hopital Haut-Leveque
Pessac, 33600
Hôpital Lyon Sud
Pierre-Bénite, Other, 69310
Centre Henri Becquerel
Rouen, 76038
CHRU Hopital de Tours
Tours, 37000
CHRU de Nancy - Hopitaux de Brabois, Service Hematologie et Medecine interne
Vandœuvre-lès-Nancy, Cedex 54511
Institut Gustave Roussy Département d'Innovations Thérapeutiques et d'Essais Précoces (DITEP)
Villejuif, 94805 Cedex
South Korea13 sites
Inje University Busan Paik Hospital
Busan, 47392
Dong-A University Hospital.
Busan, 49201
Pusan National University Hospital
Busan, 49241
Keimyung University Dongsan Hospital
Daegu, 42601
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Gachon University Gil Medical Center
Incheon, 21565
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Severance Hospital Yonsei University Health System
Seoul, 03722
SoonChunHyang University Hospital Seoul
Seoul, 04401
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul Saint Mary's Hospital
Seoul, 06591
The Catholic University of Korea
Suwon, Gyeonggi-do, 16247
Spain13 sites
Hospital del Mar
Barcelona, Other, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08029
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital San Pedro de Alcantara
Cáceres, Extremadura, 10003
Hospital San Pedro de Alcantara
Cáceres, 10005
Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Catalonia, 08908
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28080
Hospital Costa del Sol
Marbella, Malaga, 29603
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital Universitario QuironSalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario QuironSalud Madrid
Pozuelo de Alarcon (madrid), 28223
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Australia10 sites
Royal Adelaide Hospital
Adelaide, 5000
Bellberry Limited
Eastwood
Central Coast Local Health District, Gosford Hospital
Gosford, New South Wales, 2250
Central Coast Local Health District Wyong Hospital
Hamlyn Terrace, New South Wales, 2259
Royal Hobart Hospital
Hobart, Tasmania, 7000
Tasmania Health and Medical HREC
Hobart
Breakthrough Haematology Hollywood Specialist Centre
Nedlands, Western Australia, 6009
Hollywood Private Hospital
Nedlands, Western Australia, 6009
Hollywood Haematology
Nedlands, 6009
Ramsay National Research Unit and Research Governance Office
St Leonards
Taiwan9 sites
Chang Gung Medical Foundation
Kaohsiung City, 833
National Cheng Kung University Hospital
Tainan, 704
Chi Mei Hospital, Liouying
Tainan, 73657
Chi Mei Medical Center, Liouying
Tainan, 736
National Taiwan University Hospital Clinical Trial Pharmacy
Taipei, R.o.c, 100
National Taiwan University Hospital
Taipei, R.o.c, 100
Pharmacy Department, Taipei Veterans General Hospital
Taipei, 11217
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan, 333
Canada7 sites
CISSS de la Monteregie-Centre
Greenfield Park, Quebec, J4V 2H1
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H 2Y9
London Health Sciences Centre
London, Ontario, N6A 5W9
Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
Montreal, Quebec, H1T 2M4
Centre Integre Universitaire De Sante et de Services Sociaux Du Nord-de-I'ile-de-Montreal
Montreal, Quebec, H4J 1C5
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, A1B 3V6
Belgium6 sites
ZNA Middelheim
Antwerp, 2020
ZNA Cadix
Antwerp, 2030
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Chu Helora
Haine-Saint-Paul, 7100
CHU UCL Namur-
Yvoir, Namur, 5530
Italy5 sites
IRCCS Istituto Tumori Giovanni Paolo II U.O. Ematologia
Bari, Apulia, 70124
Azienda Ospedaliero-Universitaria di Bologna - IRCCS
Bologna, Other, 40138
Istituto Europeo di Oncologia
Milan, MI, 20141
Azienda Ospedaliera "Cardinale Giovanni Panico", U.O.C. Ematologia e Trapianti Midollo Osseo
Tricase, Lecce, 73039
Ospedale Maggiore ASUGI
Trieste, 34125
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, WEST Midlands, B15 2TH
St Bartholomew's hospital
London, EC1A 7BE
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
The Royal Marsden NHS Foundation Trust
Sandwich, CT13 9ND
Denmark4 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus N, 8200
Clinical Trial Unit 2081
Copenhagen, 2100
Zealand University Hospital Roskilde
Roskilde, 4000
Switzerland3 sites
Universitatsspital Basel
Basel, 4031
Kantonsspital Winterthur, Medizinische Onkologie
Winterthur, Canton of Zurich, 8401
Universitatsspital Zurich
Zurich, Other, 8091
Poland2 sites
Pratia MCM Krakow
Krakow, 30-510
Nasz Lekarz Osrodek Badan Klinicznych
Torun, 87-100
About this study
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)
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.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Brentuximab vedotin, Rituximab, Lenalidomide, Placebo
- Keywords
- Seattle Genetics
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab vedotinDrug
1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks
RituximabDrug
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.
LenalidomideDrug
20 mg given by mouth (orally) daily
PlaceboOther
Administered via intravenous infusion every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Brentuximab vedotin + lenalidomide + rituximab Receives: Drug: Brentuximab vedotin; Drug: Rituximab; Drug: Lenalidomide |
| Control Arm | Active comparator | Placebo + lenalidomide + rituximab Receives: Drug: Rituximab; Drug: Lenalidomide; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who had not died were censored at the last known alive date or the data cutoff date, whichever was earlier. OS was estimated using the Kaplan-Meier method.
Measured: From the date of randomization until date of death or censoring date, whichever occurred first (maximum up to 50 months)
Secondary outcomes (11)
Progression-Free Survival (PFS) as Assessed by Investigator Per Lugano 2014
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or to death due to any cause, whichever occurred first, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014.
Measured: From date of randomization until the first documentation of PD or to death due to any cause, whichever occurred first (maximum up to 50 months)
Objective Response Rate (ORR) as Assessed by Investigator Per Lugano 2014
ORR per Lugano 2014 by investigator was defined as the percentage of participants with a response assessment of complete response (CR) or partial response (PR) per the Lugano 2014 response criteria as assessed by the investigator.
Measured: From the date of randomization until PD or initiation of new anticancer therapy (maximum up to 50 months)
Complete Response (CR) Rate as Assessed by Investigator Per Lugano 2014
CR rate per Lugano 2014 by investigator was defined as the percentage of participants with a best response of CR per the Lugano 2014 response criteria as assessed by the investigator.
Measured: From the date of randomization until PD or initiation of new anticancer therapy (maximum up to 50 months)
Duration of Response (DOR) as Assessed by Investigator Per Lugano 2014
DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per the Lugano 2014 response criteria, as assessed by the investigator, or death due to any cause, whichever occurred first.
Measured: From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 50 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later. AEs included both serious AE (SAEs) and all other AEs. An AE was classified as an SAE if it met one of the following criteria: fatal, life threatening, required or prolonged hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant.
Measured: From first dose of study treatment (Day 1) up to 30 days after last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later (maximum up to 50 months)
Number of Participants With TEAEs Based on Maximum Severity
An AE was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later. AE severity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0 where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening; urgent intervention indicated; and grade 5= death related to AE.
Measured: From first dose of study treatment (Day 1) up to 30 days after last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later (maximum up to 50 months)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later. An AE was classified as an SAE if it met one of the following criteria: fatal, life threatening, required or prolonged hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant.
Measured: From first dose of study treatment (Day 1) up to 30 days after last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later (maximum up to 50 months)
Number of Participants With TEAEs: Through Study Completion Date
An AE was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later. AEs included both SAEs and all other AEs.
Measured: From first dose of study treatment (Day 1) through study completion
Number of Participants With TEAEs Based on Maximum Severity: Through Study Completion Date
An AE was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later. AE severity graded using the NCI-CTCAE v 5.0 where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening; urgent intervention indicated; and grade 5= death related to AE.
Measured: From first dose of study treatment (Day 1) through study completion
Number of Participants With TESAEs: Through Study Completion Date
TEAEs were defined as events that were new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of brentuximab vedotin or lenalidomide or 110 days after last dose of rituximab, whichever was later. An AE was classified as an SAE if it met one of the following criteria: fatal, life threatening, required or prolonged hospitalization, disabling/ incapacitating, congenital anomaly or birth defect, medically significant.
Measured: From first dose of study treatment (Day 1) through study completion
OS in Cluster of Differentiation 30 (CD30)-Positive Participants
OS was defined as the time from the date of randomization to the date of death due to any cause. OS was evaluated in participants with CD30 expression status using a predefined cutoff of >= 1%. Participants with CD30 tumor expression >= 1% were classified as CD30-positive. CD30 positivity was defined as >=1% of target lymphoid cells demonstrating membrane, cytoplasmic, and/or Golgi staining for CD30 at any intensity above background staining, as determined relative to the corresponding negative control. Participants who had not died were censored at the last known alive date or the data cutoff date, whichever was earlier.
Measured: From the date of randomization until date of death or censoring date, whichever occurred first (maximum up to 50 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start20 Aug 2020
- Primary completion23 Jan 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404283
- Sponsor's protocol ID
- SGN35-031
- Other IDs
- C5691003, 2023-503384-41-00, 2023
- Acronym
- ECHELON-3
- Status last verified
- Sep 2026
- First submitted
- 21 May 2020
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39772655Ward 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.
PubMed 34780623