{"entity":{"id":"transform","kind":"trial","name":"TRANSFORM","aka":[],"tldr":"The second trial to show a CAR-T beats transplant in early-relapsing large B-cell lymphoma.","summary":"TRANSFORM, trial NCT03575351 sponsored by Bristol Myers Squibb and reported in 2022, was the second trial to show that a CAR-T beats salvage chemotherapy and autologous transplant in primary refractory or early-relapsed large B-cell lymphoma. It randomised 184 transplant-eligible patients to lisocabtagene maraleucel or standard care, met its primary event-free survival endpoint with a large effect and a much higher complete response rate, and was the basis of liso-cel's second-line approval in June 2022, although crossover to liso-cel confounded overall survival. OnCo links it to lymphoma, CAR-T, CD19 as a target, the pairing of CAR-T before transplant at early relapse and the ZUMA-7 and TRANSFORM papers, and the result is concordant with ZUMA-7. Whether the two approved second-line CAR-Ts differ meaningfully in efficacy or toxicity is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03575351","url":"https://clinicaltrials.gov/study/NCT03575351"}],"tags":[],"related":["lymphoma-roadmap","belinda","transcend-nhl-001","lymphoma-ev-manufacturing-time-as-a-trial-endpoint"],"cancers":["dlbcl"],"sections":[],"technologies":["car-t"],"targets":["cd19"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03575351","phase":"3","setting":"Primary refractory or early-relapsed LBCL, transplant-eligible: liso-cel vs salvage + autologous transplant","sponsor":"BMS","result":"EFS HR 0.36; CR 74% vs 43%.","started":"2018-10-23","startedType":"actual","yearReported":2022,"enrolled":184,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Liso-cel","n":92,"value":29.5},{"name":"Standard care","n":92,"value":2.4}],"hr":0.36,"ci":[0.24,0.52],"source":"https://ashpublications.org/blood/article/141/14/1675/493918"}],"replication":"Concordant with ZUMA-7."},"route":"/trials/transform/","neighbours":{"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/"}],"trial":[{"id":"belinda","kind":"trial","name":"BELINDA","route":"/trials/belinda/"},{"id":"juliet","kind":"trial","name":"JULIET","route":"/trials/juliet/"},{"id":"transcend-nhl-001","kind":"trial","name":"TRANSCEND NHL 001","route":"/trials/transcend-nhl-001/"}],"idea":[{"id":"lymphoma-ev-manufacturing-time-as-a-trial-endpoint","kind":"idea","name":"Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote","route":"/ideas/lymphoma-ev-manufacturing-time-as-a-trial-endpoint/"}],"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"primary-mediastinal-b-cell-lymphoma","kind":"cancer","name":"Primary mediastinal (thymic) large B-cell lymphoma","route":"/cancers/primary-mediastinal-b-cell-lymphoma/"}],"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/"}],"pairing":[{"id":"car-t-before-transplant-lbcl","kind":"pairing","name":"Early relapse: CAR-T before transplant","route":"/pairings/car-t-before-transplant-lbcl/"}],"term":[{"id":"autologous-transplant","kind":"term","name":"Autologous stem cell transplant (ASCT)","route":"/terms/autologous-transplant/"},{"id":"lymphoma-tx-crs-icans","kind":"term","name":"Cytokine release syndrome and ICANS: grading and management","route":"/terms/lymphoma-tx-crs-icans/"},{"id":"lymphoma-tx-failed-and-negative","kind":"term","name":"Lymphoma treatments that did not work: the negative trials worth knowing","route":"/terms/lymphoma-tx-failed-and-negative/"},{"id":"salvage-therapy","kind":"term","name":"Salvage therapy","route":"/terms/salvage-therapy/"},{"id":"lymphoma-tx-transplant-role","kind":"term","name":"Stem cell transplant in lymphoma: what it is still for","route":"/terms/lymphoma-tx-transplant-role/"},{"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/"},{"id":"lymphoma-decision-transplant-or-car-t","kind":"term","name":"Transplant or CAR-T at second line in diffuse large B-cell lymphoma","route":"/terms/lymphoma-decision-transplant-or-car-t/"}],"paper":[{"id":"paper-transcend-nhl-001-liso-cel-lancet-2020","kind":"paper","name":"Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study","route":"/key-papers/paper-transcend-nhl-001-liso-cel-lancet-2020/"},{"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/"},{"id":"paper-transform-liso-cel-lancet-2022","kind":"paper","name":"TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma","route":"/key-papers/paper-transform-liso-cel-lancet-2022/"},{"id":"paper-zuma-7-axi-cel-second-line-nejm-2022","kind":"paper","name":"ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early","route":"/key-papers/paper-zuma-7-axi-cel-second-line-nejm-2022/"}]}}