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Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial.
Sharman JP, Egyed M, Jurczak W, Skarbnik A, Pagel JM, Flinn IW, Kamdar M, Munir T, Walewska R, Corbett G, Fogliatto LM, Herishanu Y, Banerji V, Coutre S, Follows G, Walker P, Karlsson K, Ghia P, Janssens A, Cymbalista F, Woyach JA, Salles G, Wierda WG, Izumi R, Munugalavadla V, Patel P, Wang MH, Wong S, Byrd JC. Sharman JP, et al. Lancet. 2020 Apr 18;395(10232):1278-1291. doi: 10.1016/S0140-6736(20)30262-2. Lancet. 2020. PMID: 32305093 Free PMC article. Clinical Trial.
A precision medicine classification for treatment of acute myeloid leukemia in older patients.
Mims AS, Kohlschmidt J, Borate U, Blachly JS, Orwick S, Eisfeld AK, Papaioannou D, Nicolet D, Mrόzek K, Stein E, Bhatnagar B, Stone RM, Kolitz JE, Wang ES, Powell BL, Burd A, Levine RL, Druker BJ, Bloomfield CD, Byrd JC. Mims AS, et al. J Hematol Oncol. 2021 Jun 23;14(1):96. doi: 10.1186/s13045-021-01110-5. J Hematol Oncol. 2021. PMID: 34162404 Free PMC article. Clinical Trial.
Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial.
Rosenberg L, Levaux H, Levine RL, Shah A, Denmark J, Hereema N, Owen M, Kalk S, Kenny N, Vinson G, Vergilio JA, Mims A, Borate U, Blum W, Stein E, Gana TJ, Stefanos M, Yocum A, Marcus S, Shoben A, Druker B, Byrd J, Burd A. Rosenberg L, et al. Ther Innov Regul Sci. 2021 Sep;55(5):926-935. doi: 10.1007/s43441-021-00277-w. Epub 2021 May 16. Ther Innov Regul Sci. 2021. PMID: 33997942 Free PMC article.
Ibrutinib enhances chimeric antigen receptor T-cell engraftment and efficacy in leukemia.
Fraietta JA, Beckwith KA, Patel PR, Ruella M, Zheng Z, Barrett DM, Lacey SF, Melenhorst JJ, McGettigan SE, Cook DR, Zhang C, Xu J, Do P, Hulitt J, Kudchodkar SB, Cogdill AP, Gill S, Porter DL, Woyach JA, Long M, Johnson AJ, Maddocks K, Muthusamy N, Levine BL, June CH, Byrd JC, Maus MV. Fraietta JA, et al. Blood. 2016 Mar 3;127(9):1117-27. doi: 10.1182/blood-2015-11-679134. Epub 2016 Jan 26. Blood. 2016. PMID: 26813675 Free PMC article. Clinical Trial.
Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202.
Ruppert AS, Booth AM, Ding W, Bartlett NL, Brander DM, Coutre S, Brown JR, Nattam S, Larson RA, Erba H, Litzow M, Owen C, Kuzma CS, Abramson JS, Little RF, Smith SE, Stone RM, Byrd JC, Mandrekar SJ, Woyach JA. Ruppert AS, et al. Leukemia. 2021 Oct;35(10):2854-2861. doi: 10.1038/s41375-021-01342-x. Epub 2021 Jul 17. Leukemia. 2021. PMID: 34274940 Free PMC article. Clinical Trial.
Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in mature B-cell malignancies.
Furman RR, Byrd JC, Owen RG, O'Brien SM, Brown JR, Hillmen P, Stephens DM, Chernyukhin N, Lezhava T, Hamdy AM, Izumi R, Patel P, Baek M, Christian B, Dyer MJS, Streetly MJ, Sun C, Rule S, Wang M, Ghia P, Jurczak W, Pagel JM, Sharman JP. Furman RR, et al. Leukemia. 2021 Nov;35(11):3201-3211. doi: 10.1038/s41375-021-01252-y. Epub 2021 Apr 27. Leukemia. 2021. PMID: 33907299