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Page 1
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. Among authors: stefanos m. 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.
Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the Beat AML Master Trial.
Burd A, Levine RL, Ruppert AS, Mims AS, Borate U, Stein EM, Patel P, Baer MR, Stock W, Deininger M, Blum W, Schiller G, Olin R, Litzow M, Foran J, Lin TL, Ball B, Boyiadzis M, Traer E, Odenike O, Arellano M, Walker A, Duong VH, Kovacsovics T, Collins R, Shoben AB, Heerema NA, Foster MC, Vergilio JA, Brennan T, Vietz C, Severson E, Miller M, Rosenberg L, Marcus S, Yocum A, Chen T, Stefanos M, Druker B, Byrd JC. Burd A, et al. Among authors: stefanos m. Nat Med. 2020 Dec;26(12):1852-1858. doi: 10.1038/s41591-020-1089-8. Epub 2020 Oct 26. Nat Med. 2020. PMID: 33106665 Free PMC article. Clinical Trial.
Pevonedistat with azacitidine in older patients with TP53-mutated AML: a phase 2 study with laboratory correlates.
Saliba AN, Kaufmann SH, Stein EM, Patel PA, Baer MR, Stock W, Deininger M, Blum W, Schiller GJ, Olin RL, Litzow MR, Lin TL, Ball BJ, Boyiadzis MM, Traer E, Odenike O, Arellano ML, Walker A, Duong VH, Kovacsovics T, Collins RH, Shoben AB, Heerema NA, Foster MC, Peterson KL, Schneider PA, Martycz M, Gana TJ, Rosenberg L, Marcus S, Yocum AO, Chen T, Stefanos M, Mims AS, Borate U, Burd A, Druker BJ, Levine RL, Byrd JC, Foran JM. Saliba AN, et al. Among authors: stefanos m. Blood Adv. 2023 Jun 13;7(11):2360-2363. doi: 10.1182/bloodadvances.2022008625. Blood Adv. 2023. PMID: 36315007 Free PMC article. Clinical Trial. No abstract available.
Entospletinib with decitabine in acute myeloid leukemia with mutant TP53 or complex karyotype: A phase 2 substudy of the Beat AML Master Trial.
Duong VH, Ruppert AS, Mims AS, Borate U, Stein EM, Baer MR, Stock W, Kovacsovics T, Blum W, Arellano ML, Schiller GJ, Olin RL, Foran JM, Litzow MR, Lin TL, Patel PA, Foster MC, Redner RL, Al-Mansour Z, Cogle CR, Swords RT, Collins RH, Vergilio JA, Heerema NA, Rosenberg L, Yocum AO, Marcus S, Chen T, Druggan F, Stefanos M, Gana TJ, Shoben AB, Druker BJ, Burd A, Byrd JC, Levine RL, Boyiadzis MM. Duong VH, et al. Among authors: stefanos m. Cancer. 2023 Aug 1;129(15):2308-2320. doi: 10.1002/cncr.34780. Epub 2023 Apr 20. Cancer. 2023. PMID: 37078412 Free PMC article. Clinical Trial.
Samples from patients with AML show high concordance in detection of mutations by NGS at local institutions vs central laboratories.
Borate U, Yang F, Press R, Ruppert AS, Jones D, Caruthers S, Zhao W, Vergilio JA, Pavlick DC, Juckett L, Norris B, Bucy T, Burd A, Stein EM, Patel P, Baer MR, Stock W, Schiller G, Blum W, Kovacsovics T, Litzow M, Foran J, Heerema NA, Rosenberg L, Marcus S, Yocum A, Stefanos M, Druker B, Byrd JC, Levine RL, Mims A. Borate U, et al. Among authors: stefanos m. Blood Adv. 2023 Oct 24;7(20):6048-6054. doi: 10.1182/bloodadvances.2022009008. Blood Adv. 2023. PMID: 37459200 Free PMC article.
A study to assess the efficacy of enasidenib and risk-adapted addition of azacitidine in newly diagnosed IDH2-mutant AML.
Cai SF, Huang Y, Lance JR, Mao HC, Dunbar AJ, McNulty SN, Druley T, Li Y, Baer MR, Stock W, Kovacsovics T, Blum WG, Schiller GJ, Olin RL, Foran JM, Litzow M, Lin T, Patel P, Foster MC, Boyiadzis M, Collins RH, Chervin J, Shoben A, Vergilio JA, Heerema NA, Rosenberg L, Chen TL, Yocum AO, Druggan F, Marcus S, Stefanos M, Druker BJ, Mims AS, Borate U, Burd A, Byrd JC, Levine RL, Stein EM. Cai SF, et al. Among authors: stefanos m. Blood Adv. 2024 Jan 23;8(2):429-440. doi: 10.1182/bloodadvances.2023010563. Blood Adv. 2024. PMID: 37871309 Free PMC article.
Safety and activity of BTK inhibitor ibrutinib combined with ofatumumab in chronic lymphocytic leukemia: a phase 1b/2 study.
Jaglowski SM, Jones JA, Nagar V, Flynn JM, Andritsos LA, Maddocks KJ, Woyach JA, Blum KA, Grever MR, Smucker K, Ruppert AS, Heerema NA, Lozanski G, Stefanos M, Munneke B, West JS, Neuenburg JK, James DF, Hall N, Johnson AJ, Byrd JC. Jaglowski SM, et al. Among authors: stefanos m. Blood. 2015 Aug 13;126(7):842-50. doi: 10.1182/blood-2014-12-617522. Epub 2015 Jun 26. Blood. 2015. PMID: 26116658 Free PMC article. Clinical Trial.
Beat-AML 2024 ELN-refined risk stratification for older adults with newly diagnosed AML given lower-intensity therapy.
Hoff FW, Blum WG, Huang Y, Welkie RL, Swords RT, Traer E, Stein EM, Lin TL, Archer KJ, Patel PA, Collins RH, Baer MR, Duong VH, Arellano ML, Stock W, Odenike O, Redner RL, Kovacsovics T, Deininger MW, Zeidner JF, Olin RL, Smith CC, Foran JM, Schiller GJ, Curran EK, Koenig KL, Heerema NA, Chen T, Martycz M, Stefanos M, Marcus SG, Rosenberg L, Druker BJ, Levine RL, Burd A, Yocum AO, Borate UM, Mims AS, Byrd JC, Madanat YF. Hoff FW, et al. Among authors: stefanos m. Blood Adv. 2024 Oct 22;8(20):5297-5305. doi: 10.1182/bloodadvances.2024013685. Blood Adv. 2024. PMID: 39110987 Free PMC article.