Skip to main content
. Author manuscript; available in PMC: 2021 Feb 1.
Published in final edited form as: Cytotherapy. 2020 Feb 1;22(2):57–69. doi: 10.1016/j.jcyt.2019.12.004

Table 1.

Tisagenlecleucel: pivotal clinical trials leading to approval.

Disease Primary study population Reference Sponsor Clinical trial identifier Alias Design Location Phase No. of patients infused CR/CRi at 3 months (%)
R/R CLL Adult [17, 95, 99] UPENN Single center ACC/UPENN Pilot/I 14 29
R/R B-ALL Children [100] UPENN Single center CHOP/UPENN I/IIa 30 90
Children [101] Novartis Multicenter United States II 29 69
Children [23] Novartis ELIANA Multicenter Multinational II 75 81
R/R DLBCL Adult [104] UPENN Single center ACC/UPENN IIa 14 43*
Adult [105] Novartis JULIET Multicenter Multinational II 93 40

CR, complete remission. CRi, complete remission with incomplete hematologic recovery. R/R, relapsed/refractory. CLL, chronic lymphocytic leukemia. B-ALL, B-cell acute lymphoblastic leukemia. DLBCL, diffuse large B cell lymphoma. UPENN, University of Pennsylvania. CHOP, Childrens Hospital of Philadelphia. ACC, Abramson Cancer Center.

*

Percent of patients in CR by month 6.