{"entity":{"id":"elara","kind":"trial","name":"ELARA","aka":["Tisagenlecleucel in follicular lymphoma","ELARA trial"],"tldr":"A single infusion of a patient's own reprogrammed immune cells cleared follicular lymphoma completely in about seven out of ten people who had already been through several treatments.","summary":"Follicular lymphoma relapses repeatedly and each remission tends to be shorter than the last, so the group that has exhausted antibodies, chemotherapy and often a transplant has needed something that does not depend on chemotherapy sensitivity. ELARA is the multinational phase 2 study of tisagenlecleucel in that group.\n\nOf 98 enrolled patients, 97 received the product. In the 94-patient efficacy set, the complete response rate, the primary endpoint, was 69.1 per cent (95 per cent confidence interval 58.8 to 78.3) and the overall response rate 86.2 per cent (77.5 to 92.4), at a median follow-up of 16.6 months. Within eight weeks of infusion, cytokine release syndrome occurred in 48.5 per cent with no grade 3 or worse case, neurological events in 37.1 per cent with 3 per cent grade 3 or worse, and immune effector cell-associated neurotoxicity syndrome in 4.1 per cent. There were no treatment-related deaths.\n\nThe absence of severe cytokine release syndrome is what separates this from the aggressive-lymphoma CAR-T experience and is why the treatment can be given in centres that would not attempt it in diffuse large B-cell lymphoma. ELARA, ZUMA-5 and the bispecific antibody trials together mean that early-progressing follicular lymphoma now has three chemotherapy-free options.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT03568461","url":"https://clinicaltrials.gov/study/NCT03568461"},{"label":"Nature Medicine 2022","url":"https://doi.org/10.1038/s41591-021-01622-0"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["follicular-lymphoma","non-hodgkin-lymphoma"],"sections":["cell-therapy"],"technologies":["car-t"],"targets":["cd19"],"drugs":["tisagenlecleucel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["crs","icans","complete-response","lymphoma-tx-pod24","lymphoma-tx-car-t-pathway"],"trials":["zuma-5"],"people":["catherine-thieblemont","martin-dreyling"],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":["paper-elara-tisagenlecleucel-follicular-nat-med-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03568461","phase":"2","setting":"Relapsed or refractory follicular lymphoma after two or more lines, or relapsing after an autologous transplant: a single infusion of tisagenlecleucel","sponsor":"Novartis Pharmaceuticals","result":"Complete response in 69.1 per cent and overall response in 86.2 per cent, with no grade 3 or worse cytokine release syndrome and no treatment-related deaths.","started":"2018-11-12","startedType":"actual","yearReported":2022,"enrolled":97,"enrolledBasis":"treated","enrolledNote":"The registry records 98 enrolled; 97 received tisagenlecleucel and 94 formed the efficacy set.","outcomes":[{"endpoint":"Complete response rate","primary":true,"unit":"%","arms":[{"name":"Tisagenlecleucel","n":94,"value":69.1}],"ci":[58.8,78.3],"source":"https://doi.org/10.1038/s41591-021-01622-0"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Tisagenlecleucel","n":94,"value":86.2}],"ci":[77.5,92.4]}],"replication":"Concordant with ZUMA-5, which used a different CD19 product in the same population."},"route":"/trials/elara/","neighbours":{"cancer":[{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"}],"section":[{"id":"cell-therapy","kind":"section","name":"Cell Therapy","route":"/fronts/cell-therapy/"}],"technology":[{"id":"car-t","kind":"technology","name":"CAR-T cell therapy","route":"/technologies/car-t/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"drug":[{"id":"tisagenlecleucel","kind":"drug","name":"Tisagenlecleucel","route":"/drugs/tisagenlecleucel/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"term":[{"id":"complete-response","kind":"term","name":"Complete response","route":"/terms/complete-response/"},{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"},{"id":"lymphoma-tx-pod24","kind":"term","name":"POD24: progression of follicular lymphoma within two years, and why it changes the plan","route":"/terms/lymphoma-tx-pod24/"},{"id":"lymphoma-tx-car-t-pathway","kind":"term","name":"The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting","route":"/terms/lymphoma-tx-car-t-pathway/"}],"trial":[{"id":"zuma-5","kind":"trial","name":"ZUMA-5","route":"/trials/zuma-5/"}],"person":[{"id":"catherine-thieblemont","kind":"person","name":"Catherine Thieblemont","route":"/people/catherine-thieblemont/"},{"id":"martin-dreyling","kind":"person","name":"Martin Dreyling","route":"/people/martin-dreyling/"}],"bottleneck":[{"id":"b-manufacturing-cell-therapy","kind":"bottleneck","name":"Manufacturing cost and time for living and radioactive medicines","route":"/bottlenecks/b-manufacturing-cell-therapy/"},{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"}],"paper":[{"id":"paper-zuma-5-axi-cel-indolent-lymphoma-lancet-oncol-2022","kind":"paper","name":"Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial","route":"/key-papers/paper-zuma-5-axi-cel-indolent-lymphoma-lancet-oncol-2022/"},{"id":"paper-casulo-pod24-follicular-lymphoma-jco-2015","kind":"paper","name":"Early relapse of follicular lymphoma after R-CHOP defines patients at high risk for death: an analysis from the National LymphoCare Study","route":"/key-papers/paper-casulo-pod24-follicular-lymphoma-jco-2015/"},{"id":"paper-elara-tisagenlecleucel-follicular-nat-med-2022","kind":"paper","name":"Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial","route":"/key-papers/paper-elara-tisagenlecleucel-follicular-nat-med-2022/"}],"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}]}}