TABLE 1.
ZUMA‐7 | BELINDA | TRANSFORM | |
---|---|---|---|
Locke et al. 15 2021 | Bishop et al. 16 2021 | Kamdar et al. 14 2021 | |
Autologous Anti‐CD19 CAR |
Axicabtagene ciloleucel | Tisagenlecleucel | Lisocabtagene maraleucel |
Co‐stimulatory domain | CD28 | 4‐1BB | 4‐1BB |
T‐cell selection | No | No | CD4:CD8 |
Inclusion criteria | RD and relapse <1 year | RD and relapse<1 year | RD and relapse <1 year |
LBCL |
LBCL PMBL FL3B Hx of CNS |
LBCL PMBL FL3B Sec. CNS lymphoma |
|
Randomisation | 1:1 | 1:1 | 1:1 |
Randomisation stratification |
sAAIPI RD vs. relapsed disease. |
sAAIPI RD and relapse <6 months vs. relapse 6–12 months. US vs. non‐US |
sAAIPI RD and relapse <3 months vs. relapse 3–12 months. |
Primary outcome | EFS | EFS | EFS |
Definition of EFS | Time from randomisation to death or PD, or failure to achieve CR or PR by day 150 or start of new anti‐neoplastic therapy. | Time from randomisation to SD or PD at or after the week 12 assessment or death at any time. | Time from randomisation to death or PD or failure to achieve CR or PR by 9 weeks or start of new anti‐neoplastic therapy. |
Date of initial response assessment | Day 50 and 100 |
Weeks 6 and 12 |
Weeks 9 and 18 |
CAR‐T therapy arm | |||
Bridging chemotherapy | No (only steroids) | Allowed (switching allowed) | Allowed |
Lymphodepletion | Flu 30/Cy500 mg/m2 X3d | Flu 25/Cy250 mg/m2 X3d | Flu 30/Cy300 mg/m2 X3d |
Cell dose | 2 × 106 cell/kg |
0.6‐6 × 108 cells Median 2.9 × 108 |
1 × 108 cells |
SOC arm | |||
Salvage regimen |
ICE DHAP GDP ESHAP |
ICE DHAP GDP GEMOX |
ICE DHAP GDP |
Cycle number | 2–3 | 2 (Switching allowed) | 3 |
Abbreviations: DHAP, dexamethasone‐cytarabine‐cisplatin; ESHAP, etoposide‐methylprednisolone‐cytarabine‐cisplatin; FL3B, follicular lymphoma grade 3B; GDP, gemcitabine‐dexamethasone‐cisplatin; GEMOX, gemcitabine‐oxaliplatin; ICE, ifosfamide‐carboplatin‐etoposide; PD, progressive disease; PMBL, primary mediastinal B cell lymphoma; RD, refractory disease; sAAIPI, second‐line age‐adjusted International Prognostic Index; US, United States.