Evidence map›Paper›PMID 37710005›Full record

Trial reportNature medicine2023

Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 trial.

Roch Houot, Emmanuel Bachy, Guillaume Cartron, François-Xavier Gros, Franck Morschhauser, Lucie Oberic, Thomas Gastinne, Pierre Feugier, Rémy Duléry, Catherine Thieblemont and 19 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04531046 (Phase 2, Open-Label Study Evaluating Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B-Non Hodgkin Lymphoma), which is not on this map. Cited by 66 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 5 pooled it
20.0field-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.

NCT04531046 phase2active not recruitingnot on this map

Phase 2, Open-Label Study Evaluating Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B-Non Hodgkin Lymphoma (B-NHL) Who Are Ineligible to Autologous Stem Cell Transplantation

TypeinterventionalSponsorThe Lymphoma Academic Research OrganisationRan2021 to 2026Enrolled62ConditionsB-Cell Lymphoma Refractory, B-cell Lymphoma RecurrentArmsaxicabtagene ciloleucel
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 5 syntheses or guidelines pooled it, 87 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Second Primary Malignancies after CAR T-Cell Therapy: A Systematic Review and Meta-analysis of 5,517 Lymphoma and Myeloma Patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Article
  16. Article
  17. Article
  18. Observational
  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 17 institutions in 1 country.

Roch HouotDepartment of Hematology, University Hospital of Rennes, UMR U1236, INSERM, University of Rennes, French Blood Establishment, Rennes, France. roch.houot@chu-rennes.fr.ORCID http://orcid.org/0000-0003-1729-8213
Emmanuel BachyDepartment of Hematology, Lyon Sud Hospital Center, INSERM U1111, Lyon, France.ORCID http://orcid.org/0000-0003-2694-7510
Guillaume CartronDepartment of Hematology, University Hospital of Montpellier, UMR-CNRS 5535, Montpellier, France.
François-Xavier GrosDepartment of Clinical Hematology and Cellular Therapy, University Hospital of Bordeaux, Bordeaux, France.ORCID http://orcid.org/0000-0001-8998-3039
Franck MorschhauserULR 7365 - GRITA, University Hospital of Lille, Lille, France.
Lucie ObericDepartment of Hematology, Cancer University Institute of Toulouse Oncopole, Toulouse, France.
Thomas GastinneDepartment of Hematology, University Hospital of Nantes, Nantes, France.
Pierre FeugierDepartment of Hematology, University Hospital of Nancy, INSERM 1256, University of Lorraine, Vandœuvre-lès-Nancy, France.
Rémy DuléryDepartment of Clinical Hematology and Cellular Therapy, Sorbonne University, Saint-Antoine Hospital, AP-HP, INSERM UMR938, Paris, France.
Catherine ThieblemontDepartment of Hematology and Oncology, Saint-Louis Hospital, AP-HP, Paris, France.ORCID http://orcid.org/0000-0002-9941-2448
Magalie JorisDepartment of Hematology, University Hospital of Amiens, Amiens, France.
Fabrice JardinDepartment of Clinical Hematology, Henri Becquerel Center, INSERM U1245, Rouen, France.ORCID http://orcid.org/0000-0002-6804-7943
Sylvain ChoquetDepartment of Hematology, University Hospital Pitié Salpêtrière, AP-HP, Sorbonne University, Paris, France.ORCID http://orcid.org/0000-0002-7791-0470
Olivier CasasnovasDepartment of Clinical Hematology, Dijon University Hospital, INSERM UMR1231, Dijon, France.
Gabriel BrisouDepartment of Hematology, Institut Paoli-Calmettes, Marseille, France.
Morgane CheminantDepartment of Clinical Hematology, Necker-Enfants Malades University Hospital, AP-HP, INSERM UMR1163, Paris, France.
Jacques-Olivier BayDepartment of Clinical Hematology and Cellular Therapy, Clermont-Ferrand University Hospital Center, Clermont-Ferrand, France.
Francisco Llamas GutierrezDepartment of Anatomopathology, University Hospital of Rennes, Rennes, France.
Cédric MenardFrench Blood Establishment and SITI Laboratory, UMR U1236, INSERM, University of Rennes, University Hospital Center of Rennes, Rennes, France.
Karin TarteFrench Blood Establishment and SITI Laboratory, UMR U1236, INSERM, University of Rennes, University Hospital Center of Rennes, Rennes, France.ORCID http://orcid.org/0000-0002-6809-917X
Marie-Hélène DelfauDepartment of Immunology, Henri Mondor Hospital, Créteil, France.
Cédric PortuguesDepartment of Biostatistics, LYSARC, Lyon-Sud Hospital, Pierre-Bénite, France.
Emmanuel IttiDepartment of Nuclear Medicine, Henri Mondor Hospital, Créteil, France.
Xavier Palard-NovelloDepartment of Nuclear Medicine, University of Rennes, CLCC Eugène Marquis, INSERM, Rennes, France.
Paul Blanc-DurandDepartment of Nuclear Medicine, CHU H. Mondor, U-PEC, AP-HP, Créteil, France.
Yassine Al TabaaScintidoc Nuclear Medicine Center, Clinique Clémentville, Montpellier, France.
Clément BaillyNantes-Angers Cancer Research Center CRCI2NA, University of Nantes, INSERM UMR1307, CNRS-ERL6075, Nantes, France.
Camille LaurentDepartment of Pathology, Cancer University Institute of Toulouse Oncopole, CHU Toulouse, CRCT INSERM U1037, Toulouse, France.ORCID http://orcid.org/0000-0002-5375-7512
François LemonnierLymphoid Malignancies Unit, Henri Mondor Hospital, Mondor Institute for Biomedical Research, INSERM U955, University Paris-Est, Créteil, France.
Inserm · FRAssistance Publique – Hôpitaux de Paris · FRCentre Hospitalier Universitaire Henri-Mondor · FRCentre National de la Recherche Scientifique · FRCentre Hospitalier Universitaire Amiens-Picardie · FRCentre Hospitalier Universitaire de Clermont-Ferrand · FRCentre Hospitalier Universitaire de Nantes · FRCentre Hospitalier Universitaire de Rennes · FRHôpital Lapeyronie · FRHôpital Necker-Enfants Malades · FRInstitut National Polytechnique de Toulouse · FRInstitut Pprime · FRInstitut universitaire du cancer de Toulouse Oncopole · FRSorbonne Université · FRUniversité Claude Bernard Lyon 1 · FRUniversité de Bordeaux · FRUniversité de Lille · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to standard of care as second-line therapy in patients with high-risk relapsed/refractory (R/R) large B cell lymphoma (LBCL) considered eligible for autologous stem cell transplantation (ASCT); however, in clinical practice, roughly half of patients with R/R LBCL are deemed unsuitable candidates for ASCT. The efficacy of axi-cel remains to be ascertained in transplant-ineligible patients. ALYCANTE, an open-label, phase 2 study, evaluated axi-cel as a second-line therapy in 62 patients with R/R LBCL who were considered ineligible for ASCT. The primary end point was investigator-assessed complete metabolic response at 3 months from the axi-cel infusion. Key secondary end points included progression-free survival, overall survival and safety. The study met its primary end point with a complete metabolic response of 71.0% (95% confidence interval, 58.1-81.8%) at 3 months. With a median follow-up of 12.0 months (range, 2.1-17.9), median progression-free survival was 11.8 months (95% confidence interval, 8.4-not reached) and overall survival was not reached. There was no unexpected toxicity. Grade 3-4 cytokine release syndrome and neurologic events occurred in 8.1% and 14.5% of patients, respectively. These results support axi-cel as second-line therapy in patients with R/R LBCL ineligible for ASCT. ClinicalTrials.gov Identifier: NCT04531046 .

Indexed as

Biological ProductsHematopoietic Stem Cell TransplantationLymphoma, Large B-Cell, DiffuseAntigens, CD19Cytokine Release SyndromeHumansImmunotherapy, AdoptiveTransplantation, AutologousAntigens, CD19axicabtagene ciloleucelBiological Products

Identifiers

PMID37710005
PMCPMC10579056
OpenAlexW4386741332

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.