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Bending the Curve Trial by Trial
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Назад: Неходжкинские лимфомы (диффузная В-крупноклеточная и фолликулярная лимфомы)

Список литературы: Неходжкинские лимфомы (диффузная В-крупноклеточная и фолликулярная лимфомы)

108 источников, процитированных на этой странице. Ссылки ведут к первоисточнику.

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  5. US FDA, Center for Biologics Evaluation and Research. Approval letter to Genentech, Inc. for Rituximab (Rituxan), Our Reference No. 97-0244, 26 November 1997. Источник
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  7. McLaughlin P, Grillo-López AJ, Link BK, Levy R, Czuczman MS, Williams ME, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998;16(8):2825-33. PubMedDOI
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  9. Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346(4):235-42. PubMedDOI
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  10. Ardeshna KM, Smith P, Norton A, Hancock BW, Hoskin PJ, MacLennan KA, et al. Long-term effect of a watch and wait policy versus immediate systemic treatment for asymptomatic advanced-stage non-Hodgkin lymphoma: a randomised controlled trial. Lancet. 2003;362(9383):516-22. PubMedDOI
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  13. Coiffier B, Thieblemont C, Van Den Neste E, Lepeu G, Plantier I, Castaigne S, et al. Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte. Blood. 2010;116(12):2040-5. PubMedDOI
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  14. Gisselbrecht C, Glass B, Mounier N, Singh Gill D, Linch DC, Trneny M, et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010;28(27):4184-90. PubMedDOI
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  15. Pfreundschuh M, Kuhnt E, Trümper L, Osterborg A, Trneny M, Shepherd L, et al. CHOP-like chemotherapy with or without rituximab in young patients with good-prognosis diffuse large-B-cell lymphoma: 6-year results of an open-label randomised study of the MabThera International Trial (MInT) Group. Lancet Oncol. 2011;12(11):1013-22. PubMedDOI
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  16. Salles G, Seymour JF, Offner F, López-Guillermo A, Belada D, Xerri L, et al. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011;377(9759):42-51. PubMedDOI
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  17. Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, et al. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma. J Clin Oncol. 2012;30(36):4462-9. PubMedDOI
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  18. Cunningham D, Hawkes EA, Jack A, Qian W, Smith P, Mouncey P, et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles. Lancet. 2013;381(9880):1817-26. PubMedDOI
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  19. Delarue R, Tilly H, Mounier N, Petrella T, Salles G, Thieblemont C, et al. Dose-dense rituximab-CHOP compared with standard rituximab-CHOP in elderly patients with diffuse large B-cell lymphoma (the LNH03-6B study): a randomised phase 3 trial. Lancet Oncol. 2013;14(6):525-33. PubMedDOI
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  20. Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, et al. Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013;381(9873):1203-10. PubMedDOI
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  21. Ardeshna KM, Qian W, Smith P, Braganca N, Lowry L, Patrick P, et al. Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial. Lancet Oncol. 2014;15(4):424-35. PubMedDOI
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  22. US FDA. Accelerated approval letter, Zydelig (idelalisib), NDA 205858 (relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma), signed 23 July 2014. Источник
  23. Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, et al. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014;123(19):2944-52. PubMedDOI
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  24. Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, et al. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370(11):1008-18. PubMedDOI
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  25. Crump M, Neelapu SS, Farooq U, Van Den Neste E, Kuruvilla J, Westin J, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808. PubMedDOI
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  26. Dreyling M, Santoro A, Mollica L, Leppä S, Follows GA, Lenz G, et al. Phosphatidylinositol 3-Kinase Inhibition by Copanlisib in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2017;35(35):3898-3905. PubMedDOI
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  27. US FDA. Replacement accelerated approval letter, Aliqopa (copanlisib), NDA 209936 (relapsed follicular lymphoma after at least two prior systemic therapies); effective approval date 14 September 2017. Источник
  28. US FDA. Supplement approval letter, Gazyva (obinutuzumab), BLA 125486/S-017 and S-018, signed 16 November 2017 (previously untreated stage II bulky, III or IV follicular lymphoma). Источник
  29. FDA. Approval letter, BL 125643/0 (Yescarta, axicabtagene ciloleucel), 18 October 2017. Источник
  30. Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017;377(14):1331-1344. PubMedDOI
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  31. 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(26):2531-2544. PubMedDOI
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  32. US FDA. Accelerated approval letter, Copiktra (duvelisib), NDA 211155/Original 1 (relapsed or refractory follicular lymphoma after at least two prior systemic therapies), signed 24 September 2018. Источник
  33. FDA. Supplement approval letter, BL 125646/76 (Kymriah, tisagenlecleucel; large B-cell lymphoma), 1 May 2018. Источник
  34. Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, et al. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018;379(10):934-947. PubMedDOI
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  35. Bartlett NL, Wilson WH, Jung SH, Hsi ED, Maurer MJ, Pederson LD, et al. Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. J Clin Oncol. 2019;37(21):1790-1799. PubMedDOI
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  36. FDA. Accelerated approval letter, BLA 761121 (Polivy, polatuzumab vedotin-piiq), electronic signature 10 June 2019. Источник
  37. FDA. Supplement approval letter, NDA 021880/S-057 (Revlimid, lenalidomide), electronic signature 28 May 2019: addition of previously treated follicular lymphoma and previously treated marginal zone lymphoma, each in combination with a rituximab product. Text extracted and read 21 October 2026. Источник
  38. Flinn IW, van der Jagt R, Kahl B, Wood P, Hawkins T, MacDonald D, et al. First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP: Results of the BRIGHT 5-Year Follow-Up Study. J Clin Oncol. 2019;37(12):984-991. PubMedDOI
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  39. Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, et al. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019;37(11):912-922. PubMedDOI
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  40. 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(1):45-56. PubMedDOI
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  41. Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852. PubMedDOI
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  42. FDA, Center for Drug Evaluation and Research. Accelerated approval letter, BLA 761163 (Monjuvi, tafasitamab-cxix), signed 31 July 2020. Text extracted and read 21 October 2026. Источник
  43. Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, et al. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020;38(2):155-165. PubMedDOI
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  44. FDA. Approval letter, BL 125714/0 (Breyanzi, lisocabtagene maraleucel), 5 February 2021. Источник
  45. US FDA. Replacement supplement approval letter dated 2 April 2021, Yescarta (axicabtagene ciloleucel), BL 125643/248 (relapsed or refractory follicular lymphoma, accelerated approval); effective approval date stated as 5 March 2021. Источник
  46. FDA, Center for Drug Evaluation and Research. Accelerated approval letter, BLA 761196 (Zynlonta, loncastuximab tesirine-lpyl), signed 23 April 2021. Text extracted and read 21 October 2026. Источник
  47. Fowler NH, Samaniego F, Jurczak W, Ghosh N, Derenzini E, Reeves JA, et al. Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2021;39(15):1609-1618. PubMedDOI
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  48. Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Reagan PM, Miklos DB, et al. Comparison of 2-year outcomes with CAR T cells (ZUMA-1) vs salvage chemotherapy in refractory large B-cell lymphoma. Blood Adv. 2021;5(20):4149-4155. PubMedDOI
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  49. 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(7):629-639. PubMedDOI
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  50. Budde LE, Sehn LH, Matasar M, Schuster SJ, Assouline S, Giri P, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022;23(8):1055-1065. PubMedDOI
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  51. Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, et al. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022;387(24):2220-2231. PubMedDOI
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  52. FDA. Supplement approval letter, BL 125714/90 (Breyanzi, lisocabtagene maraleucel; large B-cell lymphoma, two new indications), 24 June 2022. Источник
  53. US FDA. Supplement approval letter, 27 May 2022, Kymriah (tisagenlecleucel), BL 125646/663 (relapsed or refractory follicular lymphoma, accelerated approval). Источник
  54. US FDA. Accelerated approval letter, Lunsumio (mosunetuzumab-axgb), BLA 761263 (relapsed or refractory follicular lymphoma after two or more lines of systemic therapy), signed 22 December 2022. Источник
  55. US FDA. Drug Safety Communication of 1 June 2022: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns. Источник
  56. FDA. Supplement approval letter, BL 125643/394 (Yescarta, axicabtagene ciloleucel; second-line large B-cell lymphoma), 1 April 2022. Источник
  57. Fowler NH, Dickinson M, Dreyling M, Martinez-Lopez J, Kolstad A, Butler J, et al. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022;28(2):325-332. PubMedDOI
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  58. Jacobson CA, Chavez JC, Sehgal AR, William BM, Munoz J, Salles G, et al. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022;23(1):91-103. PubMedDOI
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  59. Kamdar M, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308. PubMedDOI
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  60. Locke FL, Miklos DB, Jacobson CA, Perales MA, Kersten MJ, Oluwole OO, et al. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022;386(7):640-654. PubMedDOI
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  61. Morschhauser F, Nastoupil L, Feugier P, Schiano de Colella JM, Tilly H, Palomba ML, et al. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R(2)) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022;40(28):3239-3245. PubMedDOI
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  62. Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trněný M, Sharman JP, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022;386(4):351-363. PubMedDOI
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  68. Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, et al. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023;41(12):2238-2247. PubMedDOI
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  70. US FDA. Supplement accelerated approval letter, 15 May 2024, Breyanzi (lisocabtagene maraleucel), BL 125714/225 (relapsed or refractory follicular lymphoma after two or more prior lines). Источник
  71. US FDA. Accelerated approval letter, Epkinly (epcoritamab-bysp), BLA 761324/S-003 (relapsed or refractory follicular lymphoma after two or more lines of systemic therapy), signed 26 June 2024. Источник
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  77. FDA. FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma. Announcement dated 11 February 2025. Page read 21 October 2026. Источник
  78. US FDA. Supplement approval letter, Epkinly (epcoritamab-bysp), BLA 761324/S-009 (new indication with lenalidomide and rituximab; conversion to traditional approval of single-agent Epkinly in follicular lymphoma), signed 18 November 2025. Источник
  79. FDA. Supplement approval letter, BLA 761163/S-013 (Monjuvi, tafasitamab-cxix), signed 18 June 2025: new indication in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma. Text extracted and read 21 October 2026; the letter contains no accelerated-approval wording. Источник
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