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. 2019 Dec 2;8:2019-8-1. doi: 10.7573/dic.2019-8-1

Table 3.

CART studies that included DHL.

Authors and study type Patient population Clinical efficacy Response durations
Abramson JS et al. JCO 2018
phase 1 TRANSCEND NHL 001 trial
91 patients received lisocabtagene maraleucel (JCAR017) (81 evaluable for efficacy) ORR: 74% in FULL dataset, 80% in CORE dataset
CR: 52% in FULL, 55% in CORE
CORE dataset, dose-level 2: ORR 50%, CR 50%
CORE dataset, dose-level 1: ORR 40%, CR 30%
Not reported
Locke FL et al. Lancet Oncol 2019
Single-arm, phase I/II ZUMA-1 trial
101 assessable patients received axicabtagene ciloleucel: 30 DEL
7 HGBL (1 THL, 4 DHL, 2 HGBL NOS)
All patients: Objective Response: 83%
CR: 58%
PR: 25%
SD: 10%
PD: 5%
DEL/HGBL patients: Objective Response: 91%
CR: 70%
All patients: Median time to response: 1 month
Median duration of response: 11.1 months
Median duration of response if CR: Not Reached
Median PFS: 5.9 months (95% CI: 3.3–15.0)
24-month PFS: 72.0% if CR at 3 months, 75.0% if PR at 3 months, 22.2% if SD at 3 months
Schuster SJ et al. NEJM 2019
Single-group phase II JULIET trial
93 patients with relapsed/refractory DLBCL received tisagenlecleucel ORR: 52% (95% CI: 41–62)
CR: 40%
PR: 12%
12-month RFS: 65% (79% among patients with CR)

CI, confidence interval; CR, complete response; DHL, double hit lymphoma; DLBCL, diffuse large B-cell lymphoma; HGBL NOS, high-grade B-cell lymphoma not otherwise specified; ORR, overall response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; RFS, relapse-free survival; SD, stable disease; THL, triple hit lymphoma.