Loading
The second trial to show a CAR-T beats transplant in early-relapsing large B-cell lymphoma.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
The reason second-line CAR-T is offered with axicabtagene ciloleucel or lisocabtagene maraleucel rather than tisagenlecleucel. The trial is also the strongest evidence in the field that the interval between apheresis and infusion, and what is given during it, is part of the treatment rather than logistics around it.
TRANSFORM confirmed ZUMA-7's conclusion with a different CD19 CAR-T and a more permissive design that allowed bridging chemotherapy, making the results closer to real-world practice. Liso-cel's low toxicity makes it attractive for older or frailer patients and for outpatient delivery. Together the two trials made CAR-T the standard second-line therapy for early-relapsing aggressive lymphoma.
ZUMA-7 rewrote second-line treatment for aggressive lymphoma: patients whose disease returns within a year of R-CHOP should be offered CAR-T rather than salvage chemotherapy and transplant. It is also one of the few cell-therapy trials to show an overall survival benefit despite crossover. Patients relapsing later than 12 months were not studied and transplant remains standard for them if chemosensitive.
The evidence that made lisocabtagene maraleucel the CD19 CAR-T product most often chosen for older or frailer patients, because its severe cytokine release syndrome rate is a fraction of the other two products'.
Shares Early relapse: CAR-T before transplant, Transplant or CAR-T at second line in diffuse large B-cell lymphoma, Lymphoma treatments that did not work: the negative trials worth knowing, Salvage therapy.
Shares TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study, TRANSCEND NHL 001.
Shares JULIET, TRANSCEND NHL 001, Cytokine release syndrome and ICANS: grading and management, Primary mediastinal (thymic) large B-cell lymphoma.
Shares Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma, ZUMA-7: axi-cel CAR-T instead of salvage chemotherapy and transplant for large B-cell lymphoma that relapses early, CD19, 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.
Shares BELINDA, JULIET, Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma, CD19.
Shares Salvage therapy, Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote, JULIET, Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma.
Shares Transplant or CAR-T at second line in diffuse large B-cell lymphoma, TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma, JULIET, Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study.
Shares Transplant or CAR-T at second line in diffuse large B-cell lymphoma, The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting, Primary mediastinal (thymic) large B-cell lymphoma, CAR-T cell therapy.