The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.
KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study
Open accessAbstract
Background: We report the pivotal phase 2 results of ZUMA-3, an international, multicenter study evaluating the efficacy and safety of the autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy KTE-X19 in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (B-ALL). Methods: Adults with relapsed/refractory B-ALL were enrolled. After leukapheresis and conditioning chemotherapy, patients received a single KTE-X19 infusion (1×106 CAR T cells/kg). The primary endpoint was the overall complete remission (CR)/CR with incomplete hematologic recovery (CRi) rate by central assessment. ZUMA-3 is registered with ClinicalTrials.gov (NCT02614066). Findings: Among 71 enrolled patients, KTE-X19 was successfully manufactured for 65 and administered to 55. The median age among treated patients was 40 years (IQR, 28–52). At the median follow-up of 16·4 months, 39 patients (70·9% [95% CI, 57–82; p<0·0001]) achieved CR/CRi, with 31 patients (56·4%) achieving CR. The medians for duration of remission, relapse-free survival, and overall survival were 12·8, 11·6, and 18·2 months, respectively. Among patients with CR/CRi, the median overall survival was not reached, and 38 patients (97%) achieved minimal residual disease negativity. Ten patients (18%) received allogeneic stem-cell transplant consolidation post–KTE-X19 infusion. The most common grade ≥3 adverse events were anemia (27 patients [49%]) and pyrexia (20 patients [36%]). Fourteen patients (25%) had grade ≥3 infections. Two grade 5 KTE-X19–related events (brain herniation; septic shock) occurred. Grade ≥3 cytokine release syndrome and neurologic events occurred in 13 (24%) and 14 patients (25%), respectively. Patient-reported outcomes indicated that most evaluable patients experienced improved or stable quality of life. Interpretation: KTE-X19 demonstrated a high CR/CRi rate in relapsed/refractory B-ALL, with the median overall survival not reached in responding patients, and a manageable safety profile. These findings indicate that KTE-X19 has the potential to confer long-term clinical benefit to adult patients with relapsed/refractory B-ALL. Funding: Kite, a Gilead company.
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Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia
Maude, S. L., Laetsch, T. W., Buechner, J., Rives, S., Boyer, M., Bittencourt, H., Bader, P., Verneris, M. R., Stefanski, H. E., Myers, G. D., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1709866 · Cited by 5,735
Self-citationCurrent concepts in the diagnosis and management of cytokine release syndrome.
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Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia
Park, J. H., Rivière, I., Gonen, M., Wang, X., Sénéchal, B., Curran, K. J., Sauter, C., Wang, Y., Santomasso, B., Mead, E., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1709919 · Cited by 2,688
Self-citationEfficacy and Toxicity Management of 19-28z CAR T Cell Therapy in B Cell Acute Lymphoblastic Leukemia
Davila, M. L., Riviere, I., Wang, X., Bartido, S., Park, J., Curran, K., Chung, S. S., Stefanski, J., Borquez-Ojeda, O., Olszewska, M., et al. (2014) · Science Translational Medicine · doi:10.1126/scitranslmed.3008226 · Cited by 2,476
Self-citationBlinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia
Kantarjian, H., Stein, A., Gökbuget, N., Fielding, A. K., Schuh, A. C., Ribera, J.-M., Wei, A., Dombret, H., Foà, R., Bassan, R., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1609783 · Cited by 2,143
Self-citationCD19 CAR–T cells of defined CD4+:CD8+ composition in adult B cell ALL patients
Turtle, C. J., Hanafi, L.-A., Berger, C., Gooley, T. A., Cherian, S., Hudecek, M., Sommermeyer, D., Melville, K., Pender, B., Budiarto, T. M., et al. (2016) · Journal of Clinical Investigation · doi:10.1172/jci85309 · Cited by 2,112
KTE-X19 CAR T cell therapy in relapsed or refractory mantle-cell lymphoma
Wang, M., Munoz, J., Goy, A., Locke, F. L., Jacobson, C. A., Hill, B. T., Timmerman, J. M., Holmes, H., Jaglowski, S., Flinn, I. W., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1914347 · Cited by 1,862
Self-citationInotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia
Kantarjian, H. M., DeAngelo, D. J., Stelljes, M., Martinelli, G., Liedtke, M., Stock, W., Gökbuget, N., O’Brien, S., Wang, K., Wang, T., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1509277 · Cited by 1,413
Self-citationAcute lymphoblastic leukemia: a comprehensive review and 2017 update
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Cappell, K. M., & Kochenderfer, J. N. (2023) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-023-00754-1 · Cited by 1,382
Promises and challenges of a decentralized CAR T-cell manufacturing model
Shah, M., Krull, A., Odonnell, L., de Lima, M. J., & Bezerra, E. (2023) · Frontiers in Transplantation · doi:10.3389/frtra.2023.1238535 · Cited by 77
Revisiting mechanisms of resistance to immunotherapies in metastatic clear-cell renal-cell carcinoma
Chatwal, M. S., Chahoud, J., & Spiess, P. E. (2023) · Cancer Drug Resistance · doi:10.20517/cdr.2023.09 · Cited by 12
Ma, J., Sarén, T., Jin, C., Kim, H. S., Contreras Pineda, P. D., de Bernard, M., Amini, R.-M., Rondahl, V., Enblad, G., Yu, D., et al. (2025) · Cancer Immunology, Immunotherapy · doi:10.1007/s00262-025-04112-1 · Cited by 1
Metadata
- Authors
- Shah, B. D., Ghobadi, A., Oluwole, O. O., Logan, A. C., Boissel, N., Cassaday, R. D., Leguay, T., Bishop, M. R., Topp, M. S., Tzachanis, D., O'Dwyer, K. M., Arellano, M. L., Lin, Y., Baer, M. R., Schiller, G. J., Park, J. H., Subklewe, M., Abedi, M., Minnema, M. C., Wierda, W. G., DeAngelo, D. J., Stiff, P., Jeyakumar, D., Feng, C., Dong, J., Shen, T., Milletti, F., Rossi, J. M., Vezan, R., Masouleh, B. K., & Houot, R.
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2021-08
- Volume
- 398
- Issue
- 10299
- Pages
- 491-502
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W3169193862
- Cited by
- 820
- References
- 28
- FWCI
- 42.23
- Type
- journal article
- Language
- en
- Open access
- green
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- CoChat. (2026). Citation check: KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. https://app.cochat.ai/papers/10.1016/s0140-6736(21)01222-8
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- Shah, B. D., Ghobadi, A., Oluwole, O. O., Logan, A. C., Boissel, N., Cassaday, R. D., Leguay, T., Bishop, M. R., Topp, M. S., Tzachanis, D., O'Dwyer, K. M., Arellano, M. L., Lin, Y., Baer, M. R., Schiller, G. J., Park, J. H., Subklewe, M., Abedi, M., Minnema, M. C., . . . Houot, R. (2021). KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. The Lancet. https://doi.org/10.1016/s0140-6736(21)01222-8
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