Evidence map›Paper›PMID 34921238›Full record

Trial reportNature medicine2022

Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial.

Nathan Hale Fowler, Michael Dickinson, Martin Dreyling, Joaquin Martinez-Lopez, Arne Kolstad, Jason Butler, Monalisa Ghosh, Leslie Popplewell, Julio C Chavez, Emmanuel Bachy and 25 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03568461 (A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel), which is not on this map. Cited by 334 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
334citing papers in PubMed, 11 pooled it
31.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03568461 phase2completednot on this map

A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma

TypeinterventionalSponsorNovartis PharmaceuticalsRan2018 to 2025Enrolled98ConditionsFollicular LymphomaArmstisagenlecleucel
3 · Its place in the literature

Who cites it

334 citing papers in PubMed, 11 syntheses or guidelines pooled it, 500 citations in OpenAlex.

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274 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors at 20 institutions in 13 countries.

Nathan Hale FowlerThe University of Texas MD Anderson Cancer Center, Houston, TX, USA. nfowler@mdanderson.org.ORCID http://orcid.org/0000-0002-9494-1877
Michael DickinsonPeter MacCallum Cancer Centre, Royal Melbourne Hospital and the Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.
Martin DreylingMedizinische Klinik III, LMU Klinikum, Munich, Germany.
Joaquin Martinez-LopezHospital 12 De Octubre, Complutense University, CNIO, Madrid, Spain.
Arne KolstadOslo University Hospital, Oslo, Norway.
Jason ButlerRoyal Brisbane Hospital, Herston, Queensland, Australia.
Monalisa GhoshMichigan Medicine University of Michigan, Ann Arbor, MI, USA.
Leslie PopplewellCity of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Julio C ChavezMoffitt Cancer Center, Tampa, FL, USA.
Emmanuel BachyHospices Civils de Lyon and Université Claude Bernard Lyon 1, Lyon, France.
Koji KatoKyushu University Hospital, Fukuoka, Japan.
Hideo HarigaeTohoku University Hospital, Sendai, Japan.ORCID http://orcid.org/0000-0003-4849-7442
Marie José KerstenAmsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.
Charalambos AndreadisHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.
Peter A RiedellUniversity of Chicago Medical Center, Chicago, IL, USA.
P Joy HoRoyal Prince Alfred Hospital and University of Sydney, Camperdown, New South Wales, Australia.
José Antonio Pérez-SimónDepartment of Hematology, University Hospital Virgen del Rocío, Instituto de Biomedicina de Sevilla, Universidad de Sevilla, Seville, Spain.
Andy I ChenOregon Health and Science University, Portland, OR, USA.
Loretta J NastoupilThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-6071-8610
Bastian von TresckowDepartment I of Internal Medicine, Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, Germany.ORCID http://orcid.org/0000-0003-1410-4487
Andrés José María FerreriLymphoma Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Takanori TeshimaHokkaido University Hospital, Sapporo, Japan.ORCID http://orcid.org/0000-0002-0941-271X
Piers E M PattenComprehensive Cancer Centre, King's College London, London, UK.
Joseph P McGuirkUniversity of Kansas Hospital and Medical Center, Westwood, KS, USA.
Andreas L PetzerInternal Medicine I, Ordensklinikum Linz Barmherzige Schwestern-Elisabethinen, Linz, Austria.
Fritz OffnerUZ Gent, Gent, Belgium.
Andreas ViardotDepartment of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.
Pier Luigi ZinzaniIRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Ram MalladiCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Aiesha ZiaNovartis Pharma AG, Basel, Switzerland.
Rakesh AwasthiNovartis Institutes for BioMedical Research, East Hanover, NJ, USA.
Aisha MasoodNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Oezlem AnakNovartis Pharma AG, Basel, Switzerland.
Stephen J SchusterLymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
Catherine ThieblemontHôpital Saint-Louis, Paris, France.ORCID http://orcid.org/0000-0002-9941-2448
Novartis (Switzerland) · CHOslo University Hospital · NOThe University of Texas MD Anderson Cancer Center · USAbbVie (United States) · USAmsterdam University Medical Centers · NLAssistance Publique – Hôpitaux de Paris · FRCambridge University Hospitals NHS Foundation Trust · GBCity Of Hope National Medical Center · USGhent University Hospital · BEHokkaido University Hospital · JPInstituto de Biomedicina de Sevilla · ESIRCCS Ospedale San Raffaele · ITIstituto di Ematologia di Bologna · ITKing's College London · GBLMU Klinikum · DEMichigan Medicine · USMoffitt Cancer Center · USNovartis (United States) · USOrdensklinikum Linz Barmherzige Schwestern · ATScripps Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor-T cell therapy with clinically meaningful outcomes demonstrated in patients with relapsed/refractory (r/r) B-cell lymphoma. In a previous pilot study of tisagenlecleucel in r/r follicular lymphoma (FL), 71% of patients achieved a complete response (CR). Here we report the primary, prespecified interim analysis of the ELARA phase 2 multinational trial of tisagenlecleucel in adults with r/r FL after two or more treatment lines or who relapsed after autologous stem cell transplant (no. NCT03568461). The primary endpoint was CR rate (CRR). Secondary endpoints included overall response rate (ORR), duration of response, progression-free survival, overall survival, pharmacokinetics and safety. As of 29 March 2021, 97/98 enrolled patients received tisagenlecleucel (median follow-up, 16.59 months; interquartile range, 13.8-20.21). The primary endpoint was met. In the efficacy set (n = 94), CRR was 69.1% (95% confidence interval, 58.8-78.3) and ORR 86.2% (95% confidence interval, 77.5-92.4). Within 8 weeks of infusion, rates of cytokine release syndrome were 48.5% (grade ≥3, 0%), neurological events 37.1% (grade ≥3, 3%) and immune effector cell-associated neurotoxicity syndrome (ICANS) 4.1% (grade ≥3, 1%) in the safety set (n = 97), with no treatment-related deaths. Tisagenlecleucel is safe and effective in extensively pretreated r/r FL, including in high-risk patients.

Indexed as

Immunotherapy, AdoptiveLymphoma, FollicularReceptors, Antigen, T-CellAdultAntigens, CD19HumansPilot ProjectsAntigens, CD19Receptors, Antigen, T-Celltisagenlecleucel

Identifiers

PMID34921238
OpenAlexW4200626931

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.