{"entity":{"id":"juliet","kind":"trial","name":"JULIET","aka":["CTL019 in diffuse large B-cell lymphoma","JULIET trial"],"tldr":"The pivotal study of the second CAR-T cell product approved for adult lymphoma, which put about a third of people with no remaining options into a lasting remission.","summary":"JULIET was the international single-arm registration study of tisagenlecleucel, an autologous CD19-directed chimeric antigen receptor T-cell product, in adults with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of therapy or after a failed autologous transplant. It ran in parallel with ZUMA-1 and used a cryopreserved apheresis product and a centralised manufacturing network, which is why its logistics, not only its biology, were studied.\n\nThe trial is in the corpus as its publication (paper-juliet-tisagenlecleucel-dlbcl-nejm-2019); the record here exists so the registry id and the study's place in the sequence have a page. Its practical importance is that it, ZUMA-1 and TRANSCEND NHL 001 together converted CAR-T from an experiment into a third line of treatment, and that the differences between their eligibility rules, bridging policies and manufacturing times explain much of the difference between their headline numbers. JULIET allowed bridging therapy and cryopreserved product; ZUMA-1 did not allow bridging.\n\nThe later randomised second-line trials split on exactly this axis. BELINDA, which tested tisagenlecleucel against salvage chemotherapy and transplant, was negative; ZUMA-7 and TRANSFORM, testing the other two products, were positive.","status":"positive","asOf":"2026-10-01","links":[{"label":"ClinicalTrials.gov NCT02445248","url":"https://clinicaltrials.gov/study/NCT02445248"},{"label":"New England Journal of Medicine 2019","url":"https://doi.org/10.1056/NEJMoa1804980"}],"tags":["lymphoma-evidence"],"related":[],"cancers":["dlbcl","non-hodgkin-lymphoma"],"sections":["cell-therapy"],"technologies":["car-t"],"targets":["cd19"],"drugs":["tisagenlecleucel"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":["crs","icans","bridging-therapy","lymphodepletion","lymphoma-tx-car-t-pathway"],"trials":["zuma-1","belinda","transform","zuma-7"],"people":["stephen-schuster"],"bottlenecks":["b-manufacturing-cell-therapy","b-global-access"],"keyPapers":["paper-juliet-tisagenlecleucel-dlbcl-nejm-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02445248","phase":"2","setting":"Relapsed or refractory diffuse large B-cell lymphoma after two or more lines, or after an autologous transplant: a single infusion of tisagenlecleucel","sponsor":"Novartis Pharmaceuticals","result":"A pivotal single-arm study supporting the approval of tisagenlecleucel in relapsed or refractory large B-cell lymphoma after two or more lines.","started":"2015-07-29","startedType":"actual","yearReported":2019,"enrolled":115,"enrolledBasis":"registry","outcomes":[],"replication":"Followed by the randomised second-line BELINDA trial, which did not show superiority over salvage chemotherapy and transplant."},"route":"/trials/juliet/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"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":"bridging-therapy","kind":"term","name":"Bridging therapy","route":"/terms/bridging-therapy/"},{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"},{"id":"lymphodepletion","kind":"term","name":"Lymphodepletion before CAR-T","route":"/terms/lymphodepletion/"},{"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":"belinda","kind":"trial","name":"BELINDA","route":"/trials/belinda/"},{"id":"transcend-nhl-001","kind":"trial","name":"TRANSCEND NHL 001","route":"/trials/transcend-nhl-001/"},{"id":"transform","kind":"trial","name":"TRANSFORM","route":"/trials/transform/"},{"id":"zuma-1","kind":"trial","name":"ZUMA-1","route":"/trials/zuma-1/"},{"id":"zuma-7","kind":"trial","name":"ZUMA-7","route":"/trials/zuma-7/"}],"person":[{"id":"stephen-schuster","kind":"person","name":"Stephen J. Schuster","route":"/people/stephen-schuster/"}],"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-juliet-tisagenlecleucel-dlbcl-nejm-2019","kind":"paper","name":"JULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma","route":"/key-papers/paper-juliet-tisagenlecleucel-dlbcl-nejm-2019/"},{"id":"paper-belinda-tisagenlecleucel-second-line-nejm-2022","kind":"paper","name":"Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma","route":"/key-papers/paper-belinda-tisagenlecleucel-second-line-nejm-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/"}]}}