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CAR T-Cell therapy shows promise against tough lymphoma in major trial

NCT ID NCT03391466

Disease control Sponsor: Kite, A Gilead Company 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether a personalized cell therapy called axicabtagene ciloleucel (Yescarta) works better than standard chemotherapy for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study enrolled 359 participants and compared event-free survival between the two groups. The goal was to see if this CAR T-cell therapy could improve outcomes for patients whose cancer returned or didn't respond to initial treatment.

What this could mean

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

Active substance
axicabtagene ciloleucel (CAR T-cell therapy)
What this could lead to
If successful, this could offer a more effective treatment option for people with hard-to-treat DLBCL, potentially improving survival without the need for a stem cell transplant.
What could go wrong
This is a completed phase 3 trial, but CAR T-cell therapy can cause serious side effects like cytokine release syndrome and neurological problems. Results may not apply to all patients.

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

359 people

The number who actually took part.

Started

Jan 2018

Finished

Nov 2024

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.

Key Inclusion Criteria: * Histologically proven large B-cell lymphoma (BCL) including the following types defined by World Health Organization (WHO) 2016. * Diffuse large B-cell lymphoma (DLBCL) not otherwise specified activated B-cell/ germinal center B-cell (ABC/GCB). * High-grade B-cell lymphoma (HGBL) with or without myelocytomatosis oncogene (MYC) and BCL 2 and/or BCL 6 rearrangement. * DLBCL arising from follicular lymphoma (FL). * T-cell/histiocyte rich large B-cell lymphoma. * DLBCL associated with chronic inflammation. * Primary cutaneous DLBCL, leg type. * Epstein-Barr virus (EBV) + DLBCL. * Relapsed or refractory disease after first-line chemoimmunotherapy. * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy. * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP). * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy. * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy. * Individuals must have received adequate first-line therapy including at a minimum: * Anti-Cluster of Differentiation 20 antigen (CD20) monoclonal antibody unless investigator determines that tumor is CD20 negative, and * An anthracycline containing chemotherapy regimen. * No known history or suspicion of central nervous system involvement by lymphoma. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1. * Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) ≥ 1000/μl * Platelet ≥ 75,000/μl * Absolute lymphocyte count ≥ 100/μl * Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) ≥ 60 mL/min. * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN). * Total bilirubin ≤ 1.5 mg/dl * Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings. * No clinically significant pleural effusion. * Baseline oxygen saturation \> 92% on room air. Key Exclusion Criteria: * History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years. * Received more than one line of therapy for DLBCL. * History of autologous or allogeneic stem cell transplant. * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. * Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or anti-hepatitis C virus (HCV) positive. If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing. * Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. * History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement. * Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted. * History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment. * History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment. * History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years. * History of anti-Cluster of Differentiation 19 (CD19) or chimeric antigen receptor (CAR)-T therapy or history of prior randomization in ZUMA-7. Note: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma Epstein-Barr virus-positive diffuse large B-cell lymphoma of the elderly follicular lymphoma high grade B-cell lymphoma primary cutaneous diffuse large B-cell lymphoma, Leg type relapsed/refractory diffuse large B-cell lymphoma T-cell/histiocyte rich large B cell lymphoma

As listed by the trial registrant

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

Relapsed/refractory diffuse large B-cell lymphoma (DLBCL)

Contacts and locations

Locations

  • Academic Medical Center

    Amsterdam, 1105 AZ, Netherlands

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Barts Health NHS Trust

    London, EC1A 7BE, United Kingdom

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus

    Québec, G1J 1Z4, Canada

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033, France

  • Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont

    Montreal, H1T 2M4, Canada

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Cliniques Universiaires Saint-Luc

    Brussels, Belgium

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Erasmus Medical Center

    Rotterdam, 3011PL, Netherlands

  • Henry-Joyce Cancer Center

    Nashville, Tennessee, 37232, United States

  • Hopital Saint-Louis

    Paris, 75010, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • IOSI, OSpedale Regionale Bellinzona e Valli

    Bellinzona, 6500, Switzerland

  • IRCCS Ospedale San Raffaele di Milano

    Milan, 20132, Italy

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Catala d'Oncologia

    Barcelona, 08908, Spain

  • Instituto di Ematologia "L. e A. Seragnoli" - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

    Bologna, 40138, Italy

  • James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic, Patient Location

    Rochester, Minnesota, 55905, United States

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1, Canada

  • Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie

    Innsbruck, 6020, Austria

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Moffitt Cancer Center

    Tampa, Florida, 12902, United States

  • Northwestern University

    Chicago, Illinois, 60612, United States

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9, Canada

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Stanford Cancer Institute

    Stanford, California, 94305, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6, Canada

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT, United Kingdom

  • The University of Kansas Cancer Center

    Kansas City, Kansas, 66160, United States

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • UCLA

    Santa Monica, California, 90404, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15213, United States

  • UZ Gasthuisberg

    Leuven, Belgium

  • Uninversity Health Network - Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9, Canada

  • Universitatsklinikum Graz, Division of Hematology

    Graz, 6020, Austria

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitatsmedizin Gottingen

    Göttingen, 37075, Germany

  • University College London Hospitals NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • University Hospital Zurich

    Zurich, 8091, Switzerland

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW, United Kingdom

  • University Medical Center Groningen

    Groningen, 9700 RB, Netherlands

  • University Medical Center Utrecht

    Utrecht, Netherlands

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Iowa Hospitals and Clinincs

    Iowa City, Iowa, 52242, United States

  • University of Maryland, Greenbaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Universitäts-klinikum Dresden

    Dresden, 01307, Germany

  • Universitäts-klinikum Würzburg

    Würzburg, 97080, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Uppsala Akademiska Sjukhus

    Uppsala, 75185, Sweden

  • Vancouver General Hospital

    Vancouver, British Columbia, Canada

  • Washington University School of Medicine

    St Louis, Missouri, 63130, United States

More trials for these conditions

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