Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a targeted drug boost survival in Hard-to-Treat lymphoma?

NCT ID NCT04404283

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether adding brentuximab vedotin to two standard drugs (lenalidomide and rituximab) helps people with diffuse large B-cell lymphoma that has returned or not improved after at least two prior treatments. About 239 participants will receive either the added drug or a placebo, and researchers will compare overall survival and cancer progression. The study is double-blind, so neither patients nor doctors know who gets the extra drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brentuximab vedotin
What this could lead to
If it works, this could offer a new treatment option for people with DLBCL that has come back or not responded to prior therapies.
What could go wrong
This is an advanced phase 3 trial, but adding brentuximab vedotin may not improve survival over standard drugs alone. Side effects from the combination could also be a concern.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

239 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diffuse large B-cell lymphoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    Aarhus N, 8200, Denmark

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliera "Cardinale Giovanni Panico", U.O.C. Ematologia e Trapianti Midollo Osseo

    Tricase, Lecce, 73039, Italy

  • Azienda Ospedaliero-Universitaria di Bologna - IRCCS

    Bologna, Other, 40138, Italy

  • Barnes Jewish-Hospital

    St Louis, Missouri, 63110, United States

  • Bellberry Limited

    Eastwood, Australia

  • Breakthrough Haematology Hollywood Specialist Centre

    Nedlands, Western Australia, 6009, Australia

  • CHRU Hopital de Tours

    Tours, 37000, France

  • CHRU de Nancy - Hopitaux de Brabois, Service Hematologie et Medecine interne

    Vandœuvre-lès-Nancy, Cedex 54511, France

  • CHU Angers - Hotel Dieu Nord, Service des Maladies du Sang

    Angers, 49933 Cedex 9, France

  • CHU Grenoble Alpes

    Grenoble, 38043 Cedex 9, France

  • CHU UCL Namur-

    Yvoir, Namur, 5530, Belgium

  • CISSS de la Monteregie-Centre

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Central Alabama Research

    Birmingham, Alabama, 35209, United States

  • Central Coast Local Health District Wyong Hospital

    Hamlyn Terrace, New South Wales, 2259, Australia

  • Central Coast Local Health District, Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Centre Antoine Lacassagne

    Nice, 06189 Cedex 2, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Le Mans

    Le Mans, 72000, France

  • Centre Hospitalier Metropole Savoie

    Chambéry, 73000, France

  • Centre Hospitalier Regional Metz-Thionville Hopital Mercy Service d'hematologie

    Metz, 57085, France

  • Centre Hospitalier Sud Francilien (CHSF)

    Corbeil-Essonnes, 91106 cedex, France

  • Centre Hospitalier Universitaire Nantes-Hotel Dieu, Service d'Hematologie

    Nantes, Cedex 144093, France

  • Centre Hospitalier(CH) de Perpignan

    Perpignan, Other, 66000, France

  • Centre Integre Universitaire De Sante et de Services Sociaux Du Nord-de-I'ile-de-Montreal

    Montreal, Quebec, H4J 1C5, Canada

  • Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,

    Montreal, Quebec, H1T 2M4, Canada

  • Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie

    Bordeaux, Other, 33000, France

  • Chang Gung Medical Foundation

    Kaohsiung City, 833, Taiwan

  • Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • Chi Mei Hospital, Liouying

    Tainan, 73657, Taiwan

  • Chi Mei Medical Center, Liouying

    Tainan, 736, Taiwan

  • Chu Helora

    Haine-Saint-Paul, 7100, Belgium

  • Clinical Trial Unit 2081

    Copenhagen, 2100, Denmark

  • Dong-A University Hospital.

    Busan, 49201, South Korea

  • Eastern Regional Health Authority

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Florida Cancer Specialists

    Bonita Springs, Florida, 34135, United States

  • Florida Cancer Specialists

    Bradenton, Florida, 34211, United States

  • Florida Cancer Specialists

    Cape Coral, Florida, 33909, United States

  • Florida Cancer Specialists

    Daytona Beach, Florida, 32117, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908, United States

  • Florida Cancer Specialists

    Naples, Florida, 34102, United States

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34232, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34236, United States

  • Florida Cancer Specialists

    Stuart, Florida, 34994, United States

  • Florida Cancer Specialists

    Venice, Florida, 34285, United States

  • Florida Cancer Specialists

    Venice, Florida, 34292, United States

  • Florida Cancer Specialists

    Vero Beach, Florida, 32960, United States

  • Florida Cancer Specialists

    Wellington, Florida, 33414, United States

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Henry Ford Medical Center - Columbus

    Novi, Michigan, 48377, United States

  • Hollywood Haematology

    Nedlands, 6009, Australia

  • Hollywood Private Hospital

    Nedlands, Western Australia, 6009, Australia

  • Hopital Saint-Antoine -

    Paris, 75012, France

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Costa del Sol

    Marbella, Malaga, 29603, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, Extremadura, 10003, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, 10005, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28080, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario QuironSalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario QuironSalud Madrid

    Pozuelo de Alarcon (madrid), 28223, Spain

  • Hospital de Navarra

    Pamplona, Navarre, 31008, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08029, Spain

  • Hospital del Mar

    Barcelona, Other, 08003, Spain

  • Hôpital Lyon Sud

    Pierre-Bénite, Other, 69310, France

  • IRCCS Istituto Tumori Giovanni Paolo II U.O. Ematologia

    Bari, Apulia, 70124, Italy

  • Inje University Busan Paik Hospital

    Busan, 47392, South Korea

  • Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

    L'Hospitalet de Llobregat, Catalonia, 08908, Spain

  • Institut Gustave Roussy Département d'Innovations Thérapeutiques et d'Essais Précoces (DITEP)

    Villejuif, 94805 Cedex, France

  • Istituto Europeo di Oncologia

    Milan, MI, 20141, Italy

  • Jeonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907, South Korea

  • Kantonsspital Winterthur, Medizinische Onkologie

    Winterthur, Canton of Zurich, 8401, Switzerland

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Karmanos Cancer Institute Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334, United States

  • Keimyung University Dongsan Hospital

    Daegu, 42601, South Korea

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • MidAmerica Division, Inc. c/o Centerpoint Medical Center

    Independence, Missouri, 64057, United States

  • MidAmerica Division, Inc. c/o Menorah Medical Center

    Overland Park, Kansas, 66209, United States

  • MidAmerica Division, Inc., c/o Research Medical Center

    Kansas City, Missouri, 64132, United States

  • Nasz Lekarz Osrodek Badan Klinicznych

    Torun, 87-100, Poland

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, R.o.c, 100, Taiwan

  • National Taiwan University Hospital Clinical Trial Pharmacy

    Taipei, R.o.c, 100, Taiwan

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401, United States

  • Oncology_Hematology Care Clinical Trials,LLC

    Cincinnati, Ohio, 45211, United States

  • Oncology_Hematology Care Clinical Trials,LLC

    Cincinnati, Ohio, 45236, United States

  • Oncology_Hematology Care Clinical Trials,LLC

    Cincinnati, Ohio, 45242, United States

  • Oncology_Hematology Care Clinical Trials,LLC

    Cincinnati, Ohio, 45245, United States

  • Oncology_Hematology Care Clinical Trials,LLC

    Fairfield, Ohio, 45014, United States

  • Ospedale Maggiore ASUGI

    Trieste, 34125, Italy

  • Pharmacy Department, Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Pratia MCM Krakow

    Krakow, 30-510, Poland

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Queen Elizabeth II Health Science Centre

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Ramsay National Research Unit and Research Governance Office

    St Leonards, Australia

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29414, United States

  • Roper St. Francis Healthcare

    Mt. Pleasant, South Carolina, 29464, United States

  • Roper St. Francis Healthcare

    North Charleston, South Carolina, 29406, United States

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Service d'Hematologie Clinique

    Limoges, 87042, France

  • Service d'Hematologie clinique et Therapie cellulaire CHU Bordeaux Hopital Haut-Leveque

    Pessac, 33600, France

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Siteman Cancer Center - North County

    St Louis, Missouri, 63136, United States

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129, United States

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141, United States

  • SoonChunHyang University Hospital Seoul

    Seoul, 04401, South Korea

  • St Bartholomew's hospital

    London, EC1A 7BE, United Kingdom

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tasmania Health and Medical HREC

    Hobart, Australia

  • The Catholic University of Korea

    Suwon, Gyeonggi-do, 16247, South Korea

  • The Catholic University of Korea, Seoul Saint Mary's Hospital

    Seoul, 06591, South Korea

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    Sandwich, CT13 9ND, United Kingdom

  • US Oncology Investigational Products Center

    Irving, Texas, 75063, United States

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitatsspital Basel

    Basel, 4031, Switzerland

  • Universitatsspital Zurich

    Zurich, Other, 8091, Switzerland

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, WEST Midlands, B15 2TH, United Kingdom

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Virginia Cancer Center.

    Charlottesville, Virginia, 22903, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • West Chester Hospital

    West Chester, Ohio, 45069, United States

  • ZNA Cadix

    Antwerp, 2030, Belgium

  • ZNA Middelheim

    Antwerp, 2020, Belgium

  • Zealand University Hospital Roskilde

    Roskilde, 4000, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.