Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma

Completed · Phase 3

Conditions studied: Non-Hodgkin Lymphoma

In brief

This is a randomized, open label, multicenter phase III trial comparing the efficacy, safety, and tolerability of tisagenlecleucel to Standard Of Care in adult patients with aggressive B-cell Non-Hodgkin Lymphoma after failure of rituximab and anthracycline containing frontline immunochemotherapy.

Key facts

Study ID

NCT03570892

Run by

Novartis Pharmaceuticals

People needed

330

Starts

2019-05-09

Expected to finish

2026-02-03

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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))

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Sarah Cannon Research Institute — Denver, Colorado, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Uni of Chi Medi Ctr Hema and Onco — Chicago, Illinois, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• Wayne State University-Karmanos Cancer Institute — Detroit, Michigan, United States
• Uni of Nebraska Med Ctr — Omaha, Nebraska, United States
• Hackensack Uni Medical Center — Hackensack, New Jersey, United States
• Jewish Hospital — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Oregon Health Sciences Univ — Portland, Oregon, United States
• Uni Pennsylvania Abramson Cncr Ctr — Philadelphia, Pennsylvania, United States
• MUSC Hollings Cancer Center — Charleston, South Carolina, United States
• Tennessee Oncology PLLC — Chattanooga, Tennessee, United States
• St Davids South Austin Medical Ctr — Austin, Texas, United States
• Texas Oncology-Baylor Scott and White — Dallas, Texas, United States
• Uni of Texas MD Anderson Ca Center — Houston, Texas, United States
• Methodist Hospital — San Antonio, Texas, United States
• Uni of Wisconsin Carbone Cancer Ctr — Madison, Wisconsin, United States
• Novartis Investigative Site — Darlinghurst, New South Wales, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Murdoch, Western Australia, Australia
• Moores UC San Diego Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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