Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-Cell lymphoma

New England Journal of Medicine

Volumn 377, Issue 26, 2017, Pages 2531-2544

  Neelapu, S S ^a   Locke, F L ^b   Bartlett, N L ^c   Lekakis, L J ^d   Miklos, D B ^e   Jacobson, C A ^j   Braunschweig, I ^k   Oluwole, O O ^m   Siddiqi, T ^f   Lin, Y ^o   Timmerman, J M ^g   Stiff, P J ^p   Friedberg, J W ^l   Flinn, I W ⁿ   Goy, A ^q   Hill, B T ^r   Smith, M R ^r   Deol, A ^s   Farooq, U ^t   McSweeney, P ^u   Munoz, J ^v   Avivi, I ^w   Castro, J E ^h   Westin, J R ^a   Chavez, J C ^b   Ghobadi, A ^c   Komanduri, K V ^d   Levy, R ^e   Jacobsen, E D ^j   Witzig, T E ^o   Reagan, P ^l   Bot, A ⁱ   Rossi, J ⁱ   Navale, L ⁱ   Jiang, Y ⁱ   Aycock, J ⁱ   Elias, M ⁱ   Chang, D ⁱ   Wiezorek, J ⁱ   Go, W Y ⁱ   more..

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^c USA   (United States)

^d UNIVERSITY OF MIAMI   (United States)

^e STANFORD UNIVERSITY   (United States)

^f CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ Kite Pharma   (United States)

^j DANA FARBER CANCER INSTITUTE   (United States)

^k MONTEFIORE MEDICAL CENTER   (United States)

^l UNIVERSITY OF ROCHESTER   (United States)

^m VANDERBILT UNIVERSITY   (United States)

ⁿ SARAH CANNON RESEARCH INSTITUTE   (United States)

^o MAYO CLINIC   (United States)

^p LOYOLA UNIVERSITY CHICAGO   (United States)

^q HACKENSACK UNIVERSITY MEDICAL CENTER   (United States)

^r LERNER RESEARCH INSTITUTE   (United States)

^s KARMANOS CANCER INSTITUTE   (United States)

^t UNIVERSITY OF IOWA   (United States)

^u Rocky Mountain Blood and Marrow Transplant Program   (United States)

^v Banner MD Anderson Cancer Center   (United States)

^w TEL AVIV UNIVERSITY   (Israel)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AXICABTAGENE CILOLEUCEL; CHIMERIC ANTIGEN RECEPTOR; CYCLOPHOSPHAMIDE; CYTOKINE; FLUDARABINE; TUMOR MARKER; BIOLOGICAL MARKER; CD19 ANTIGEN; INTERLEUKIN DERIVATIVE; LYMPHOCYTE ANTIGEN RECEPTOR;

ADULT; AGED; AGITATION; ANEMIA; APHASIA; ARTICLE; AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION; BONE MARROW SUPPRESSION; BRAIN DISEASE; CANCER GRADING; CANCER SURVIVAL; CHILL; CONFUSION; CONSTIPATION; CONTROLLED STUDY; CYTOKINE RELEASE; DEATH; DECREASED APPETITE; DIARRHEA; DIFFUSE LARGE B CELL LYMPHOMA; DISEASE MARKER; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; FOLLICULAR LYMPHOMA; FOLLOW UP; HEADACHE; HUMAN; HUMAN CELL; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOTENSION; HYPOXIA; LARGE CELL LYMPHOMA; LEUKOPENIA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM CANCER; MEMORY DISORDER; MENTAL DISEASE; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SINUS TACHYCARDIA; SOMNOLENCE; T LYMPHOCYTE; TACHYCARDIA; THROMBOCYTOPENIA; TRANSPLANTATION CONDITIONING; TREATMENT RESPONSE; TREMOR; VOMITING; ADOPTIVE IMMUNOTHERAPY; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; DISEASE FREE SURVIVAL; IMMUNOLOGY; MIDDLE AGED; MORTALITY; NEUROLOGIC DISEASE; SURVIVAL RATE; TRANSPLANTATION; YOUNG ADULT;

ADULT; AGED; ANTIGENS, CD19; BIOMARKERS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; IMMUNOTHERAPY, ADOPTIVE; INTERLEUKINS; LYMPHOMA, LARGE B-CELL, DIFFUSE; MALE; MIDDLE AGED; NERVOUS SYSTEM DISEASES; NEUTROPENIA; RECEPTORS, ANTIGEN, T-CELL; SURVIVAL RATE; T-LYMPHOCYTES; YOUNG ADULT;

EID: 85040170618     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1707447     Document Type: Article

References (35)

1. Sehn LH, Gascoyne RD. Diffuse large B-cell lymphoma: Optimizing outcome in the context of clinical and biologic heterogeneity. Blood 2015; 125: 22-32.
2. Dunleavy K, Wilson WH. Primary mediastinal B-cell lymphoma and mediastinal gray zone lymphoma: Do they require a unique therapeutic approach? Blood 2015; 125: 33-9.
3. Casulo C, Burack WR, Friedberg JW. Transformed follicular non-Hodgkin lymphoma. Blood 2015; 125: 40-7.
4. Ardeshna KM, Kakouros N, Qian W, et al. Conventional second-line salvage chemotherapy regimens are not warranted in patients with malignant lymphomas who have progressive disease after firstline salvage therapy regimens. Br J Haematol 2005; 130: 363-72.
5. Hitz F, Connors JM, Gascoyne RD, et al. Outcome of patients with primary refractory diffuse large B cell lymphoma after R-CHOP treatment. Ann Hematol 2015; 94: 1839-43.
6. Josting A, Reiser M, Rueffer U, Salzberger B, Diehl V, Engert A. Treatment of primary progressive Hodgkin's and aggressive non-Hodgkin's lymphoma: Is there a chance for cure? J Clin Oncol 2000; 18: 332-9.
7. Matasar MJ, Czuczman MS, Rodriguez MA, et al. Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade Bcell lymphoma. Blood 2013; 122: 499-506.
8. Moskowitz CH, Bertino JR, Glassman JR, et al. Ifosfamide, carboplatin, and etoposide: A highly effective cytoreduction and peripheral-blood progenitor-cell mobilization regimen for transplant-eligible patients with non-Hodgkin's lymphoma. J Clin Oncol 1999; 17: 3776-85.
9. Nagle SJ, Woo K, Schuster SJ, et al. Outcomes of patients with relapsed/refractory diffuse large B-cell lymphoma with progression of lymphoma after autologous stem cell transplantation in the rituximab era. Am J Hematol 2013; 88: 890-4.
10. Philip T, Guglielmi C, Hagenbeek A, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med 1995; 333: 1540-5.
11. Seshadri T, Stakiw J, Pintilie M, Keating A, Crump M, Kuruvilla J. Utility of subsequent conventional dose chemotherapy in relapsed/refractory transplanteligible patients with diffuse large B-cell lymphoma failing platinum-based salvage chemotherapy. Hematology 2008; 13: 261-6.
12. Telio D, Fernandes K, Ma C, et al. Salvage chemotherapy and autologous stem cell transplant in primary refractory diffuse large B-cell lymphoma: Outcomes and prognostic factors. Leuk Lymphoma 2012; 53: 836-41.
13. Friedberg JW. Relapsed/refractory diffuse large B-cell lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011: 498-505.
14. Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: Results from the international SCHOLAR-1 study. Blood 2017; 130: 1800-8.
15. Kochenderfer JN, Dudley ME, Feldman SA, et al. B-cell depletion and remissions of malignancy along with cytokineassociated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells. Blood 2012; 119: 2709-20.
16. Kochenderfer JN, Dudley ME, Kassim SH, et al. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol 2015; 33: 540-9.
17. Kochenderfer JN, Somerville RPT, Lu T, et al. Long-duration complete remissions of diffuse large B cell lymphoma after anti-CD19 chimeric antigen receptor T cell therapy. Mol Ther 2017; 25: 2245-53.
18. Schuster S, Svoboda J, Nasta S, et al. Sustained remissions following chimeric antigen receptor modified T cells directed against CD19 (CTL019) in patients with relapsed or refractory CD19+ lymphomas. Blood 2015; 126: 183.
19. Turtle CJ, Hanafi LA, Berger C, et al. Immunotherapy of non-Hodgkin's lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cells. Sci Transl Med 2016; 8: 355ra116.
20. Kochenderfer JN, Feldman SA, Zhao Y, et al. Construction and preclinical evaluation of an anti-CD19 chimeric antigen receptor. J Immunother 2009; 32: 689-702.
21. Locke FL, Neelapu SS, Bartlett NL, et al. Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther 2017; 25: 285-95.
22. WHO classification of tumours of haematopoietic and lymphoid tissue. 4th ed. Geneva: World Health Organization, 2008.
23. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007; 25: 579-86.
24. Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of cytokine release syndrome. Blood 2014; 124: 188-95.
25. Kochenderfer JN, Somerville RPT, Lu T, et al. Lymphoma remissions caused by anti-CD19 chimeric antigen receptor T cells are associated with high serum interleukin-15 levels. J Clin Oncol 2017; 35: 1803-13.
26. Scott DW, Wright GW, Williams PM, et al. Determining cell-of-origin subtypes of diffuse large B-cell lymphoma using gene expression in formalin-fixed paraffin-embedded tissue. Blood 2014; 123: 1214-7.
27. Neelapu SS, Tummala S, Kebriaei P, et al. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol 2017 September 19 (Epub ahead of print).
28. Klyuchnikov E, Bacher U, Kroll T, et al. Allogeneic hematopoietic cell transplantation for diffuse large B cell lymphoma: who, when and how? Bone Marrow Transplant 2014; 49: 1-7.
29. Kawalekar OU, O'Connor RS, Fraietta JA, et al. Distinct signaling of coreceptors regulates specific metabolism pathways and impacts memory development in CAR T cells. Immunity 2016; 44: 380-90.
30. Zhao Z, Condomines M, van der Stegen SJC, et al. Structural design of engineered costimulation determines tumor rejection kinetics and persistence of CAR T cells. Cancer Cell 2015; 28: 415-28.
31. Park JH, Brentjens RJ. Are all chimeric antigen receptors created equal? J Clin Oncol 2015; 33: 651-3.
32. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med 2014; 371: 1507-17.
33. Davila ML, Riviere I, Wang X, et al. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Sci Transl Med 2014; 6: 224ra25.
34. Turtle CJ, Hanafi LA, Berger C, et al. CD19 CAR-T cells of defined CD4+:CD8+ composition in adult B cell ALL patients. J Clin Invest 2016; 126: 2123-38.
35. Teachey DT, Lacey SF, Shaw PA, et al. Identification of predictive biomarkers for cytokine release syndrome after chimeric antigen receptor T-cell therapy for acute lymphoblastic leukemia. Cancer Discov 2016; 6: 664-79.