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. 2024 Nov 7;14(1):197.
doi: 10.1038/s41408-024-01183-8.

Is CAR T a drug or a therapeutic pathway? Intention to treat versus per protocol analysis of real world studies of CAR-T cell therapy in relapsed refractory diffuse large B cell lymphoma

Rossana Di Staso  1 , Beatrice Casadei  2 , Frederick L Locke  3 , Michael Jain  3 , Timothy J Voorhees  4 , Adam S Kittai  4 , Mariana Bastos-Oreiro  5 , Antonio Gutiérrez  6 , Alejandro Martin Garcia-Sancho  7 , Maria Jose Terol  8 , Monica Mead  9 , Michael J Maranzano  10 , Gloria Iacoboni  11   12 , Pere Barba  11   12 , Mi Kwon  13 , Rebeca Bailen  13 , Juan Luis Reguera-Ortega  14 , Agrima Mian  15 , Brian Hill  15 , Emmanuel Bachy  16 , Franck Morschhauser  17 , Roch Houot  18 , Catherine Thieblemont  19 , Steven Le Gouill  20 , Riccardo Masetti  1 , Davide Gori  21 , Alessandro Broccoli  1   2 , Pier Luigi Zinzani  1   2 , Lisa Argnani  22
Affiliations

Is CAR T a drug or a therapeutic pathway? Intention to treat versus per protocol analysis of real world studies of CAR-T cell therapy in relapsed refractory diffuse large B cell lymphoma

Rossana Di Staso et al. Blood Cancer J. .
No abstract available

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Conflict of interest statement

GI served as consultant and received honoraria from Novartis, Roche, Kite/Gilead, Bristol-Myers Squibb, Abbvie, Janssen, Sandoz, Miltenyi, AstraZeneca. PB as consultant and received honoraria from Allogene, Amgen, Autolus, BMS/Celgene, Kite/Gilead, Incyte, Miltenyi Biomedicine, Novartis, Nektar, Pfizer, Pierre Fabre. JLR served as consultant and received honoraria from Johnson&Johnson, Kite/Gilead, Novartis, BMS and Sanofi. RH served as consultant and received honoraria from Kite/Gilead, Novartis, Incyte, Janssen, MSD, Takeda, Roche, Bristol-Myers Squibb/Celgene, ADC Therapeutics, Incyte, Miltenyi. AMG served as consultant and received honoraria from Roche, BMS, Takeda, Janssen, Kyowa Kirin, Gilead/Kite, Incyte, Lilly, Miltenyi, Ideogen, Genmab, AbbVie, Sobi, AstraZeneca, GSK. MBO served as consultant and received honoraria from Roche, BMS, Novartis, Janssen, Kyowa Kirin, Gilead/Kite, Incyte, Lilly, Genmab, AbbVie, Sobi, AstraZeneca. The remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Forest plot of the subgroup analysis according to study location was conducted.
A CRR ITT; B CRR PP; C ORR ITT; D ORR PP. CRR complete response rate, ITT intention-to-treat, ORR overall response rate, PP per protocol.
See this image and copyright information in PMC

References

    1. Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, et al. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017;377:2531–44. - PMC - PubMed
    1. Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, et al. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2019;380:45–56. - PubMed
    1. Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20:31–42. - PMC - PubMed
    1. Bishop MR, Dickinson M, Purtill D, Barba P, Santoro A, Hamad N, et al. Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma. N Engl J Med. 2022;386:629–39. - PubMed
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