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Enregistrement W4407288611 · doi:10.1136/jitc-2024-009890

Real-world outcomes with tisagenlecleucel in aggressive B-cell lymphoma: subgroup analyses from the CIBMTR registry

2025· article· en· W4407288611 sur OpenAlexafffund
Daniel J. Landsburg, Matthew J. Frigault, Michael Heim, S.R. Foley, Brian T. Hill, Grant Schofield, Caron A. Jacobson, Samantha Jaglowski, Frederick L. Locke, Ron Ram, Peter A. Riedell, Gunjan L. Shah, Leslie Popplewell, Ranjan Tiwari, Stephen Lim, Marta Majdan, Aisha Masood, Marcelo C. Pasquini, Cameron J. Turtle

Notice bibliographique

RevueJournal for ImmunoTherapy of Cancer · 2025
Typearticle
Langueen
DomaineMedicine
ThématiqueCAR-T cell therapy research
Établissements canadiensMcMaster UniversityJuravinski Hospital
Organismes subventionnairesIovance BiotherapeuticsJanssen Research and DevelopmentNational Institute of Allergy and Infectious DiseasesNational Cancer InstituteOffice of Naval ResearchNational Heart, Lung, and Blood Institutebluebird bioPharmacyclicsTakeda OncologyLegend BiotechU.S. NavyAdaptive BiotechnologiesHealth Resources and Services AdministrationNational Institutes of HealthCytoSen TherapeuticsMorphoSysCareDxBeiGeneSwedish Orphan BiovitrumAstellas PharmaCSL BehringKyowa Kirin Pharmaceutical DevelopmentAtara BiotherapeuticsVertex PharmaceuticalsAnthem FoundationGlaxoSmithKlineKiadis PharmaSanofiTG TherapeuticsMedacJazz PharmaceuticalsOmeros CorporationU.S. Department of DefenseMedical College of WisconsinStemCyteAbbVieActinium PharmaceuticalsGilead SciencesStanford UniversityNational Marrow Donor ProgramMallinckrodt PharmaceuticalsMerckBristol-Myers SquibbAstraZenecaAstellas Pharma USBe The Match FoundationNovartis Pharmaceuticals CorporationDana-Farber Cancer InstituteAllogene TherapeuticsIncytePfizerAmgenBoston Children's HospitalHistoGenetics
Mots-clésMedicineCytokine release syndromeFludarabineInternal medicineOncologyHematopoietic stem cell transplantationDiffuse large B-cell lymphomaSalvage therapyCohortLymphomaTransplantationChimeric antigen receptorImmunotherapyChemotherapyCancerCyclophosphamide

Résumé

récupéré en direct d'OpenAlex

BACKGROUND: Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown similar efficacy and improved safety compared with previous clinical trials. However, long-term data on real-world outcomes are lacking. METHODS: Clinical data from a cohort of patients treated with tisagenlecleucel in a real-world setting were captured in the Center for International Blood and Marrow Transplant Research registry. The main clinical outcomes analysed included response rate, duration of response, survival, adverse events and clinicopathologic and treatment characteristics that may affect those outcomes. RESULTS: As of May 2022, 1159 patients with R/R DLBCL/HGBCL received tisagenlecleucel. The overall response rate was 59.5%, and the complete response rate was 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 month rates of progression-free survival, ongoing response and overall survival were 28.4%, 52.6% and 43.6%, respectively. Grade ≥3 cytokine release syndrome and neurotoxicity were reported in 6% and 7.4% of patients, respectively. Patients with DLBCL (vs HGBCL), complete response before infusion, prior autologous or allogeneic haematopoietic stem cell transplant and lactate dehydrogenase (LDH) within normal limits experienced more favourable efficacy outcomes, and those with Eastern Cooperative Oncology Group performance status of ≥2, ≥3 prior lines of therapy, elevated LDH and fludarabine-based lymphodepleting chemotherapy experienced less favourable safety outcomes. CONCLUSIONS: This real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.Tisagenlecleucel, a CD19 chimeric antigen receptor T-cell therapy, is approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after ≥2 lines of therapy. When used in real-world settings, tisagenlecleucel has shown similar efficacy and improved safety compared with previous clinical trials. However, long-term data on real-world outcomes are lacking.Clinical data from a cohort of patients treated with tisagenlecleucel in a real-world setting were captured in the Center for International Blood and Marrow Transplant Research registry. The main clinical outcomes analysed included response rate, duration of response, survival, adverse events, and clinicopathologic and treatment characteristics that may affect those outcomes.As of May 2022, 1159 patients with R/R DLBCL/HGBCL received tisagenlecleucel. The overall response rate was 59.5%, and the complete response rate was 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 month rates of progression-free survival, ongoing response, and overall survival were 28.4%, 52.6%, and 43.6%, respectively. Grade ≥3 cytokine release syndrome and neurotoxicity were reported in 6% and 7.4% of patients, respectively. Patients with DLBCL (vs HGBCL), complete response before infusion, prior autologous or allogeneic haematopoietic stem cell transplant, and lactate dehydrogenase (LDH) within normal limits experienced more favourable efficacy outcomes, and those with Eastern Cooperative Oncology Group performance status ≥2, ≥3 prior lines of therapy, elevated LDH, and fludarabine-based lymphodepleting chemotherapy experienced less favourable safety outcomes.In conclusion, this real-world study of tisagenlecleucel for patients with R/R DLBCL/HGBCL shows consistent efficacy and better safety outcomes than the pivotal trial. This study also identifies baseline disease characteristics and prior or concurrent treatments that may affect clinical outcomes.

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.

Comment cette classification a été obtenuedéplier

Prédiction distillée sur la base complète

Imitation des enseignants

Ni prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.

score de la tête « metaresearch » (Codex)0,000
score de la tête « metaresearch » (Gemma)0,000
Version: codex-gemma-dda1882f352aStatut de validation: machine_predicted_unvalidated
Catégories candidatesCharge utile insuffisante (le modèle a refusé de juger)
Catégories consensuellesaucune
DomaineSignal candidat: aucune · Signal consensuel: aucune
Devis d'étudeSignal candidat: Observationnel · Signal consensuel: aucune
GenreSignal candidat: Empirique · Signal consensuel: Empirique
Score de désaccord entre enseignants0,331
Score d'incertitude au seuil1,000

Scores Codex et Gemma par catégorie

CatégorieCodexGemma
Métarecherche0,0000,000
Méta-épidémiologie (sens strict)0,0000,000
Méta-épidémiologie (sens large)0,0010,000
Bibliométrie0,0000,001
Études des sciences et des technologies0,0000,000
Communication savante0,0000,000
Science ouverte0,0000,000
Intégrité de la recherche0,0000,000
Charge utile insuffisante (le modèle a refusé de juger)0,0010,000

Scores machine (provisoires)

Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.

Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.

Tête enseignante Opus0,040
Tête enseignante GPT0,411
Écart entre enseignants0,371 · la distance entre les deux têtes enseignantes sur ce seul travail
Statut de validationscore_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle

Classification

machine, non validée

Prédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.

Devis d'étudeObservationnel
Domainenon disponible
GenreEmpirique

Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».

En bref

Citations13
Publié2025
Routes d'admission2
Résumé présentoui

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