Onco Wiki / Regimen

Lisocabtagene maraleucel (liso-cel) CAR-T 2L for primary-refractory or early-relapse LBCL (TRANSFORM)

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Notes

CD19 CAR-T (4-1BB costimulation) with defined 1:1 CD4:CD8 cell composition for primary-refractory LBCL or relapse <12 months from completion of first-line therapy. TRANSFORM phase 3 RCT (Kamdar et al., Lancet 2022; long-term update Abramson et al., Blood 2023): liso-cel superior to standard-of-care salvage chemo + autoSCT in transplant-intended 2L primary-refractory / early-relapse LBCL — median EFS 10.1 vs 2.3 mo (HR ~0.36), CR ~74% vs ~43%, PFS substantially extended; OS trend favourable but crossover-confounded. Boxed warnings: CRS, ICANS, secondary T-cell malignancy (FDA 2024 class label). REMS / FACT-JACIE-accredited centre mandatory. Eligibility narrower than 3L: primary-refractory or early-relapse + transplant-intent. Distinct from REGIMEN-LISOCEL-DLBCL-3L (TRANSCEND, ≥3L any-comer). Trial source SRC-TRANSFORM-KAMDAR-2022 absent from KB at chunk authoring time — citing NCCN-BCELL-2025 + ESMO-DLBCL-2024 pending source-stub creation.

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