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CAR-T therapy takes on standard care in lymphoma battle

NCT ID NCT03570892

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether the CAR-T cell therapy tisagenlecleucel works better than standard treatments for adults with aggressive B-cell non-Hodgkin lymphoma that came back or didn't respond to initial therapy. The study enrolled 330 participants and compared how long they lived without the disease getting worse. The goal is to see if this personalized cell therapy can improve outcomes for this hard-to-treat cancer.

What this could mean

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

Active substance
Tisagenlecleucel (a CAR-T cell therapy)
What this could lead to
If successful, this could offer a more effective treatment option for adults with aggressive B-cell non-Hodgkin lymphoma that has not responded to initial therapy.
What could go wrong
This is a completed Phase 3 trial, but results may not show a clear benefit over standard care. CAR-T therapy can cause serious side effects like cytokine release syndrome and neurological issues.

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

330 people

The number who actually took part.

Started

May 2019

Finished

Feb 2026

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 to 100 years

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: * Histologically confirmed, aggressive B-cell NHL at relapse/progression or PR after front line therapy. Aggressive B-cell NHL is heretofore defined by the following list of subtypes (Swerdlow et al 2016): * DLBCL, NOS, * FL grade 3B, * Primary mediastinal large B cell lymphoma (PMBCL), * T cell rich/histiocyte rich large B cell lymphoma (T/HRBCL), * DLBCL associated with chronic inflammation, * Intravascular large B-cell lymphoma, * ALK+ large B-cell lymphoma, * B-cell lymphoma, unclassifiable, (with features intermediate between DLBCL and classical Hodgkin's Lymphoma (HL)), * High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, * High-grade B-cell lymphoma, NOS * HHV8+ DLBCL, NOS * DLBCL transforming from follicular lymphoma * DLBCL transforming from marginal zone lymphoma * DLBCL, leg type * Relapse or progression within 365 days from last dose of anti CD20 antibody and anthracycline containing first line immunochemotherapy or refractory (have not achieved a CR). * Patient is considered eligible for autologous HSCT as per local investigator assessment. Note: Intention to transplant and type of high dose chemotherapy (HDCT) regimen will be documented at the time of study entry * Disease that is both active on PET scan (defined as 5-Deauville scorepoint-scale of 4 or 5) and measurable on CT scan, defined as:: * Nodal lesions \>15 mm in the long axis, regardless of the length of the short axis, and/or * Extranodal lesions (outside lymph node or nodal mass, but including liver and spleen) \>10 mm in long AND short axis * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate organ function: Renal function defined as: * Serum creatinine of ≤1.5 x upper limit of normal (ULN), OR estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 Hepatic function defined as: * Alanine Transaminase (ALT) and Aspartate Transiminase (AST) ≤ 5 × ULN * Total bilirubin ≤ 1.5 x ULN with the exception of patients with Gilbert syndrome who may be included if their total bilirubin is ≤3.0 × ULN and direct bilirubin ≤1.5 × ULN Hematologic Function (regardless of transfusions) defined as: * Absolute neutrophil count (ANC) \>1000/mm3 * Absolute lymphocyte count (ALC) \>300/mm3 OR Absolute number of CD3+ T cells \>150/mm3 (only for patients with non-historical apheresis) * Platelets ≥50000/mm3 * Hemoglobin \>8.0 g/dl Adequate pulmonary function defined as: * No or mild dyspnea (≤ Grade 1) * Oxygen saturation measured by pulse oximetry \> 90% on room air * Forced expiratory volume in 1 s (FEV1) ≥ 50% and/or carbon monoxide diffusion test (DLCO) ≥50% of predicted level - Must have a leukapheresis material of non-mobilized cells available for manufacturing. Exclusion Criteria: * Prior treatment with anti-CD19 therapy, T cell therapy, or any prior gene therapy product * Treatment with any systemic lymphoma-directed second line anticancer therapy prior to randomization. Only steroids and local irradiation are permitted for disease control * Patients with active central nervous system (CNS) involvement by disease under study are excluded, except if the CNS involvement has been effectively treated and local treatment was \>4 weeks before randomization * Prior allogeneic HSCT * Clinically significant active infection * Any of the following cardiovascular conditions: * Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening, * Left ventricle ejection fraction (LVEF) \<45% as determined by echocardiogram (ECHO) or magnetic resonance angiography (MRA) or multigated acquisition (MUGA) at the screening assessment. * New York Heart Association (NYHA) functional class III or IV (Chavey et al 2001), within the past 12 months. * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II) and third degree AV block unless adequately controlled by pacemaker implantation. * Resting QTcF ≥450 msec (male) or ≥460 msec (female) at screening or inability to determine the QTcF interval * Risk factors for Torsades de Pointes (TdP), including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/ symptomatic bradycardia, or any of the following: * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome * Concomitant medication(s) with a "Known Risk of Torsades de Pointes" per crediblemeds.org that cannot be discontinued or replaced by safe alternative medication. * Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré Syndrome (GBS), Amyotrophic Lateral Sclerosis (ALS)) and clinically significant active cerebrovascular disorders (e.g. cerebral edema, posterior reversible encephalopathy syndrome (PRES))

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Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell neoplasm diffuse large B-cell lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

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

Non-Hodgkin lymphoma

Contacts and locations

Locations

  • Emory University

    Atlanta, Georgia, 30329, United States

  • Hackensack Uni Medical Center

    Hackensack, New Jersey, 07601, United States

  • Jewish Hospital

    Cincinnati, Ohio, 45236, United States

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Moores UC San Diego Cancer Center

    La Jolla, California, 92093, United States

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3000, Australia

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150, Australia

  • Novartis Investigative Site

    Salzburg, 5020, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Novartis Investigative Site

    São Paulo, 05651-901, Brazil

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Beijing, 100191, China

  • Novartis Investigative Site

    Shanghai, 200065, China

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Oslo, 0310, Norway

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Novartis Investigative Site

    London, NW1 2BU, United Kingdom

  • Oregon Health Sciences Univ

    Portland, Oregon, 97239, United States

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218, United States

  • St Davids South Austin Medical Ctr

    Austin, Texas, 78704, United States

  • Tennessee Oncology PLLC

    Chattanooga, Tennessee, 37404, United States

  • Texas Oncology-Baylor Scott and White

    Dallas, Texas, 75231, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • Uni Pennsylvania Abramson Cncr Ctr

    Philadelphia, Pennsylvania, 19104, United States

  • Uni of Chi Medi Ctr Hema and Onco

    Chicago, Illinois, 60637, United States

  • Uni of Nebraska Med Ctr

    Omaha, Nebraska, 68198, United States

  • Uni of Texas MD Anderson Ca Center

    Houston, Texas, 77030, United States

  • Uni of Wisconsin Carbone Cancer Ctr

    Madison, Wisconsin, 53792-6164, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66205, United States

  • Wayne State University-Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

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