Resolution of the Council of Experts “Issues of using CAR-T drugs in the treatment of B-cell acute lymphoblastic leukemia”

1. Henze G., Stackelberg A., Eckert C. ALL-REZ BFM-The consecutive trials for children with relapsed acute lymphoblastic leukemia. Klin Padiatr. 2013;225 Suppl 1:S73–8. doi: 10.1055/s-0033-1337967.

2. Moricke A., Zimmermann M., Reiter A., Henze G., Schrauder A. Gadner H., Ludwig W.D., Ritter J., Harbott J., Mann G., Klingebiel T., Zintl F., Niemeyer C., Kremens B., Niggli F., Niethammer D., Welte K., Stanulla M., Odenwald E., Riehm H., Schrappe M. Longterm results of five consecutive trials in childhood acute lymphoblastic leukemia performed by the ALL-BFM study group from 1981 to 2000. Leukemia. 2010;24(2):265–84. doi: 10.1038/leu.2009.257.

3. Oskarsson T., Soderholl S., Arvidson J., Forestier E., Montgomery S., Bottai M., Lausen B., Carlsen N., Hellebostad M., Lähteenmäki P., Saarinen-Pihkala U.M., Jónsson Ó.G., Heyman M.; Nordic Society of Paediatric Haematology and Oncology (NOPHO). ALL relapse working group Relapsed childhood acute lymphoblastic leukemia in the Nordic countries: prognostic factors, treatment and outcome. Haematologica. 2016;101(1):68–76. doi: 10.3324/haematol.2015.131680.

4. Parker C., Waters R., Leighton C., Hancock J., Sutton R., Moorman A.V., Ancliff P., Morgan M., Masurekar A., Goulden N., Green N., Révész T., Darbyshire P., Love S., Saha V. Effect of mitoxantrone on outcome of children with first relapse of acute lymphoblastic leukaemia (ALL R3): an open-label randomized trial. Lancet. 2010;376(9757):2009–17. doi: 10.1016/S0140-6736(10)62002-8.

5. Ko R.H., Ji L., Barnette P., Bostrom B., Hutchinson R., Raetz E., Seibel N.L., Twist C.J., Eckroth E., Sposto R., Gaynon P.S., Loh M.L. Outcome of patients treated for relapsed or refractory acute lymphoblastic leukemia: a Therapeutic Advances in Childhood Leukemia Consortium study. J Clin Oncol. 2010;28(4):648–54. doi: 10.1200/JCO.2009.22.2950.

6. Clinical guidelines “Acute lymphoblastic leukemia”, ID: 529. [Electronic resource]: URL: https://cr.minzdrav.gov.ru/recom end/529?ysclid=lz7apqka7c882238403 (appeal date 20.05.2024). (In Russ.).

7. Clinical guidelines “Acute lymphoblastic leukemia”, ID: 496. [Electronic resource]: URL: https://cr.minzdrav.gov.ru/recomend/496_1 (appeal date 20.05.2024). (In Russ.).

8. 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., Qayed M., de Moerloose B., Hiramatsu H., Schlis K., Davis K.L., Martin P.L., Nemecek E.R., Yanik G.A., Peters C., Baruchel A., Boissel N., Mechinaud F., Balduzzi A., Krueger J., June C.H., Levine B.L., Wood P., Taran T., Leung M., Mueller K.T., Zhang Y., Sen K., Lebwohl D., Pulsipher M.A., Grupp S.A. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018;378(5):439–48. doi: 10.1056/nejmoa1709866.

9. 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. 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. Lancet. 2021;398(10299):491–502. doi: 10.1016/S0140-6736(21)01222-8.

10. Gavrilina O.A., Galstyan G.M., Shchekina A.E., Kotova E.S., Maschan M.A., Troitskaya V.V., Koroleva D.A., Zvonkov E.E., Fidarova Z.T., Vasilyeva V.A., Parovichnikova E.N. Chimeric antigen receptor T-cell therapy in adult patients with B-cell lymphoproliferative diseases. Gematologiya i transfuziologiya = Russian Journal of Hematology and Transfusiology. 2022;67(1):8–28. (In Russ.). doi: 10.35754/02345730-2022-67-1-8-28.

11. June C.H., O’Connor R.S., Kawalekar O.U., Ghassemi S., Milone M.C. CAR T cell immunotherapy for human cancer. Science. 2018;359(6382):1361–5. doi: 10.1126/science.aar6711.

12. FDA approval brings first gene therapy to the United States [news release] Silver Spring, MD: US Food and Drug Administration [Electronic resource]: URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm (appeal date 20.05.2024).