Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL (ECHELON-3)

April 17, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • Eastwood, Australia
        • Bellberry Limited
      • Greenslopes, Australia
        • Ramsay National Research Unit and Research Governance Office
      • Hobart, Australia
        • Tasmania Health and Medical HREC
      • Nedlands, Australia, 6009
        • Hollywood Haematology
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Central Coast Local Health District, Gosford Hospital
      • Hamlyn Terrace, New South Wales, Australia, 2259
        • Central Coast Local Health District Wyong Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Hollywood Private Hospital
      • Nedlands, Western Australia, Australia, 6009
        • Breakthrough Haematology Hollywood Specialist Centre
  • Belgium
      • Antwerp, Belgium, 2020
        • ZNA Middelheim
      • Antwerp, Belgium, 2030
        • ZNA Cadix
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Haine-Saint-Paul, Belgium, 7100
        • CHU Helora
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • CHU UCL Namur-
  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Eastern Regional Health Authority
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Science Centre
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital - General Campus
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CISSS de la Monteregie-Centre
      • Montreal, Quebec, Canada, H4J 1C5
        • Centre Integre Universitaire De Sante et de Services Sociaux Du Nord-de-I'ile-de-Montreal
      • Montreal, Quebec, Canada, H1T 2M4
        • Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Clinical Trial Unit 2081
      • Roskilde, Denmark, 4000
        • Zealand University Hospital Roskilde
  • France
      • Angers, France, 49933 Cedex 9
        • CHU Angers - Hotel Dieu Nord, Service des Maladies du Sang
      • Chambéry, France, 73000
        • Centre Hospitalier Metropole Savoie
      • Corbeil-Essonnes, France, 91106 cedex
        • Centre Hospitalier Sud Francilien (CHSF)
      • Grenoble, France, 38043 Cedex 9
        • CHU Grenoble Alpes
      • Le Mans, France, 72000
        • Centre Hospitalier Le Mans
      • Limoges, France, 87042
        • Service d'Hematologie Clinique
      • Metz, France, 57085
        • Centre Hospitalier Regional Metz-Thionville Hopital Mercy Service d'hematologie
      • Nantes, France, Cedex 144093
        • Centre Hospitalier Universitaire Nantes-Hotel Dieu, Service d'Hematologie
      • Nice, France, 06189 Cedex 2
        • Centre Antoine Lacassagne
      • Paris, France, 75012
        • Hopital Saint-Antoine -
      • Pessac, France, 33600
        • Service d'Hematologie clinique et Therapie cellulaire CHU Bordeaux Hopital Haut-Leveque
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Tours, France, 37000
        • CHRU Hopital de Tours
      • Vandœuvre-lès-Nancy, France, Cedex 54511
        • CHRU de Nancy - Hopitaux de Brabois, Service Hematologie et Medecine interne
      • Villejuif, France, 94805 Cedex
        • Institut Gustave Roussy Département d'Innovations Thérapeutiques et d'Essais Précoces (DITEP)
    • Other
      • Bordeaux, Other, France, 33000
        • Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie
      • Perpignan, Other, France, 66000
        • Centre Hospitalier(CH) de Perpignan
      • Pierre-Bénite, Other, France, 69310
        • Hôpital Lyon Sud
  • Italy
      • Trieste, Italy, 34125
        • Ospedale Maggiore ASUGI
    • Apulia
      • Bari, Apulia, Italy, 70124
        • IRCCS Istituto Tumori Giovanni Paolo II U.O. Ematologia
    • Lecce
      • Tricase, Lecce, Italy, 73039
        • Azienda Ospedaliera "Cardinale Giovanni Panico", U.O.C. Ematologia e Trapianti Midollo Osseo
    • MI
      • Milan, MI, Italy, 20141
        • Istituto Europeo di Oncologia
    • Other
      • Bologna, Other, Italy, 40138
        • Azienda Ospedaliero-Universitaria di Bologna - IRCCS
  • Poland
      • Krakow, Poland, 30-510
        • PRATIA MCM Kraków
      • Torun, Poland, 87-100
        • Nasz Lekarz Osrodek Badan Klinicznych
  • South Korea
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Busan, South Korea, 47392
        • Inje University Busan Paik Hospital
      • Busan, South Korea, 49201
        • Dong-A University Hospital.
      • Daegu, South Korea, 42601
        • Keimyung University Dongsan Hospital
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 04401
        • Soonchunhyang University Hospital Seoul
      • Seoul, South Korea, 06591
        • The Catholic University of Korea, Seoul Saint Mary's Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Suwon, Gyeonggi-do, South Korea, 16247
        • The Catholic University of Korea
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea, 54907
        • Jeonbuk National University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08029
        • Hospital De La Santa Creu I Sant Pau
      • Cáceres, Spain, 10005
        • Hospital San Pedro de Alcantara
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28080
        • Hospital Universitario Fundacion Jimenez Diaz
      • Pozuelo de Alarcon (madrid), Spain, 28223
        • Hospital Universitario Quironsalud Madrid
      • Salamanca, Spain, 37007
        • Hospital Clínico Universitario de Salamanca
    • Catalonia
      • L'Hospitalet de Llobregat, Catalonia, Spain, 08908
        • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
    • Extremadura
      • Cáceres, Extremadura, Spain, 10003
        • Hospital San Pedro de Alcantara
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
    • Malaga
      • Marbella, Malaga, Spain, 29603
        • Hospital Costa Del Sol
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Hospital De Navarra
    • Other
      • Barcelona, Other, Spain, 08003
        • Hospital del Mar
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsspital Basel
    • Canton of Zurich
      • Winterthur, Canton of Zurich, Switzerland, 8401
        • Kantonsspital Winterthur, Medizinische Onkologie
    • Other
      • Zurich, Other, Switzerland, 8091
        • Universitätsspital Zürich
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Chang Gung Medical Foundation
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 73657
        • Chi Mei Hospital, Liouying
      • Tainan, Taiwan, 736
        • Chi Mei Medical Center, Liouying
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Pharmacy Department, Taipei Veterans General Hospital
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
    • R.o.c
      • Taipei, R.o.c, Taiwan, 100
        • National Taiwan University Hospital Clinical Trial Pharmacy
      • Taipei, R.o.c, Taiwan, 100
        • National Taiwan University Hospital
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • Sandwich, United Kingdom, CT13 9ND
        • The Royal Marsden NHS Foundation Trust
    • WEST Midlands
      • Birmingham, WEST Midlands, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Central Alabama Research
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
    • Florida
      • Bonita Springs, Florida, United States, 34135
        • Florida Cancer Specialists
      • Bradenton, Florida, United States, 34211
        • Florida Cancer Specialists
      • Cape Coral, Florida, United States, 33909
        • Florida Cancer Specialists
      • Daytona Beach, Florida, United States, 32117
        • Florida Cancer Specialists
      • Fort Myers, Florida, United States, 33905
        • Florida Cancer Specialists
      • Fort Myers, Florida, United States, 33908
        • Florida Cancer Specialists
      • Naples, Florida, United States, 34102
        • Florida Cancer Specialists
      • Port Charlotte, Florida, United States, 33980
        • Florida Cancer Specialists
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists
      • Sarasota, Florida, United States, 34236
        • Florida Cancer Specialists
      • Stuart, Florida, United States, 34994
        • Florida Cancer Specialists
      • Venice, Florida, United States, 34285
        • Florida Cancer Specialists
      • Venice, Florida, United States, 34292
        • Florida Cancer Specialists
      • Vero Beach, Florida, United States, 32960
        • Florida Cancer Specialists
      • Wellington, Florida, United States, 33414
        • Florida Cancer Specialists
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • MidAmerica Division, Inc. c/o Menorah Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Comprehensive Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Farmington Hills, Michigan, United States, 48334
        • Karmanos Cancer Institute Weisberg Cancer Treatment Center
      • Novi, Michigan, United States, 48377
        • Henry Ford Medical Center - Columbus
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center - St. Peters
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center - West County
      • Independence, Missouri, United States, 64057
        • MidAmerica Division, Inc. c/o Centerpoint Medical Center
      • Kansas City, Missouri, United States, 64132
        • MidAmerica Division, Inc., c/o Research Medical Center
      • St Louis, Missouri, United States, 63110
        • Barnes Jewish-Hospital
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine - Siteman Cancer Center
      • St Louis, Missouri, United States, 63129
        • Siteman Cancer Center - South County
      • St Louis, Missouri, United States, 63136
        • Siteman Cancer Center - North County
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cincinnati, Ohio, United States, 45211
        • Oncology_Hematology Care Clinical Trials,LLC
      • Cincinnati, Ohio, United States, 45236
        • Oncology_Hematology Care Clinical Trials,LLC
      • Cincinnati, Ohio, United States, 45242
        • Oncology_Hematology Care Clinical Trials,LLC
      • Cincinnati, Ohio, United States, 45245
        • Oncology_Hematology Care Clinical Trials,LLC
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center IDS Pharmacy
      • Fairfield, Ohio, United States, 45014
        • Oncology_Hematology Care Clinical Trials,LLC
      • West Chester, Ohio, United States, 45069
        • West Chester Hospital
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon, P.C.
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Roper St. Francis Healthcare
      • Mt. Pleasant, South Carolina, United States, 29464
        • Roper St. Francis Healthcare
      • North Charleston, South Carolina, United States, 29406
        • Roper St. Francis Healthcare
    • Texas
      • Irving, Texas, United States, 75063
        • US Oncology Investigational Products Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Cancer Center.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

    1. 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
    2. Active disease following induction and salvage chemotherapy
    3. Inadequate stem cell mobilization (for HSCT)
    4. Relapse following prior HSCT or CAR-T
    5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm
Brentuximab vedotin + lenalidomide + rituximab
Drug: Brentuximab vedotin
1.2 mg/kg administered into the vein (IV; intravenously) infusion every 3 weeks
Drug: Rituximab
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.
Drug: Lenalidomide
20 mg given by mouth (orally) daily
Active Comparator: Control Arm
Placebo + lenalidomide + rituximab
Drug: Rituximab
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.
Drug: Lenalidomide
20 mg given by mouth (orally) daily
Other: Placebo
Administered via intravenous infusion every 3 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Approximately 2 years
OS is defined as the time from the date of randomization to date of death due to any cause
Approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: 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.
Approximately 1 year
Progression-free survival (PFS)
Time Frame: 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)
Approximately 1 year
Objective response rate (ORR)
Time Frame: 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).
Approximately 1 year
Complete response (CR) rate
Time Frame: Approximately 1 year
Proportion of participants with best response of CR according to investigator assessment per the Lugano Criteria for Response Assessment (Cheson 2014)
Approximately 1 year
Duration of response (DOR)
Time Frame: 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.
Approximately 1 year
OS in CD30+ participants
Time Frame: Approximately 2 years
Time from the date of randomization to date of death due to any cause.
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seagen, a wholly owned subsidiary of Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGN35-031
  • C5691003 (Other Identifier: Alias Study Number)
  • 2023-503384-41-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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Clinical Trials on Diffuse Large B-cell Lymphoma

Clinical Trials on Brentuximab vedotin

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