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Randomized phase 1 study of sequential ("primed") vs. concurrent decitabine in combination with cladribine, cytarabine, G-CSF, and mitoxantrone (CLAG-M) in adults with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) or other high-grade myeloid neoplasm.

作者信息

Palmieri Raffaele, Buckley Sarah A, Othus Megan, Halpern Anna B, Percival Mary-Elizabeth M, Scott Bart L, Hendrie Paul C, Becker Pamela S, Oehler Vivian G, Estey Elihu H, Walter Roland B

机构信息

Clinical Research Division, Fred Hutchinson Cancer Research Center/University of Washington, Seattle, WA, USA.

Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

出版信息

Leuk Lymphoma. 2020 Jul;61(7):1728-1731. doi: 10.1080/10428194.2020.1728754. Epub 2020 Feb 20.

DOI:10.1080/10428194.2020.1728754
PMID:32077361
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7384960/
Abstract
摘要

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1
Randomized phase 1 study of sequential ("primed") vs. concurrent decitabine in combination with cladribine, cytarabine, G-CSF, and mitoxantrone (CLAG-M) in adults with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) or other high-grade myeloid neoplasm.在新诊断或复发/难治性急性髓系白血病(AML)或其他高级别髓系肿瘤成人患者中,进行地西他滨序贯(“预激”)与同步给药联合克拉屈滨、阿糖胞苷、粒细胞集落刺激因子(G-CSF)和米托蒽醌(CLAG-M)的随机1期研究。
Leuk Lymphoma. 2020 Jul;61(7):1728-1731. doi: 10.1080/10428194.2020.1728754. Epub 2020 Feb 20.
2
Decitabine as epigenetic priming with CLAG induce improved outcome of relapsed or refractory acute myeloid leukemia in children.地西他滨联合 CLAG 方案作为表观遗传学诱导剂改善复发或难治性儿童急性髓系白血病的疗效。
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Medicine (Baltimore). 2018 Sep;97(39):e12102. doi: 10.1097/MD.0000000000012102.
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Decitabine plus CLAG chemotherapy as a bridge to haploidentical transplantation in the setting of acute myeloid leukemia relapse after HLA-matched sibling transplantation: a case report.地西他滨联合 CLAG 化疗桥接 HLA 匹配同胞供体移植后急性髓系白血病复发行单倍体相合移植:1 例报告。
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Cladribine combined with high doses of arabinoside cytosine, mitoxantrone, and G-CSF (CLAG-M) is a highly effective salvage regimen in patients with refractory and relapsed acute myeloid leukemia of the poor risk: a final report of the Polish Adult Leukemia Group.克拉屈滨联合大剂量阿糖胞苷、米托蒽醌和粒细胞集落刺激因子(CLAG-M)是一种治疗预后不良的难治性和复发性急性髓系白血病患者的高效挽救方案:波兰成人白血病组的最终报告
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Mitoxantrone, etoposide and cytarabine following epigenetic priming with decitabine in adults with relapsed/refractory acute myeloid leukemia or other high-grade myeloid neoplasms: a phase 1/2 study.在复发/难治性急性髓系白血病或其他高级别髓系肿瘤成人患者中,地西他滨进行表观遗传预处理后使用米托蒽醌、依托泊苷和阿糖胞苷:一项1/2期研究
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Case Report: Decitabine and venetoclax sequentially followed by FLAG-Ida and venetoclax with immediate allogeneic stem cell transplantation in newly diagnosed acute myeloid leukemia with chromosome 3 inversion/ rearrangement.病例报告:在新诊断的伴有3号染色体倒位/重排的急性髓系白血病中,先序贯使用地西他滨和维奈克拉,随后使用FLAG-Ida和维奈克拉,并立即进行异基因造血干细胞移植。
Front Oncol. 2025 Mar 27;15:1530852. doi: 10.3389/fonc.2025.1530852. eCollection 2025.
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A hybrid protocol CLAG-M, a possible player for the first-line therapy of patients with mixed phenotype acute leukemia. A Polish Adult Leukemia Group experience.一种混合方案CLAG-M,可能是混合表型急性白血病患者一线治疗的选择。波兰成人白血病组的经验。
Front Oncol. 2024 May 21;14:1395992. doi: 10.3389/fonc.2024.1395992. eCollection 2024.
3
Decitabine as epigenetic priming with CLAG induce improved outcome of relapsed or refractory acute myeloid leukemia in children.地西他滨联合 CLAG 方案作为表观遗传学诱导剂改善复发或难治性儿童急性髓系白血病的疗效。
Clin Epigenetics. 2024 May 9;16(1):63. doi: 10.1186/s13148-024-01677-z.
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本文引用的文献

1
CLAG-M with dose-escalated mitoxantrone for adults with acute myeloid leukemia.联合剂量递增米托蒽醌的CLAG-M方案用于治疗成人急性髓系白血病。
Oncotarget. 2018 Nov 27;9(93):36543-36544. doi: 10.18632/oncotarget.26383.
2
Phase I/II trial of cladribine, high-dose cytarabine, mitoxantrone, and G-CSF with dose-escalated mitoxantrone for relapsed/refractory acute myeloid leukemia and other high-grade myeloid neoplasms.针对复发/难治性急性髓系白血病及其他高级别髓系肿瘤,进行克拉屈滨、大剂量阿糖胞苷、米托蒽醌和粒细胞集落刺激因子联合剂量递增米托蒽醌的I/II期试验。
Haematologica. 2019 Apr;104(4):e143-e146. doi: 10.3324/haematol.2018.204792. Epub 2018 Nov 8.
3
Acute myeloid leukemia: 2019 update on risk-stratification and management.急性髓细胞白血病:2019 年风险分层和治疗策略更新。
Am J Hematol. 2018 Oct;93(10):1267-1291. doi: 10.1002/ajh.25214.
4
Phase 1/2 trial of GCLAM with dose-escalated mitoxantrone for newly diagnosed AML or other high-grade myeloid neoplasms.GCLAM 联合剂量递增米托蒽醌治疗初诊 AML 或其他高级别髓系肿瘤的 1/2 期临床试验。
Leukemia. 2018 Nov;32(11):2352-2362. doi: 10.1038/s41375-018-0135-8. Epub 2018 Apr 17.
5
Epigenetic therapy: azacytidine and decitabine in acute myeloid leukemia.表观遗传疗法:急性髓系白血病中的阿扎胞苷和地西他滨
Expert Rev Hematol. 2018 May;11(5):361-371. doi: 10.1080/17474086.2018.1453802. Epub 2018 Mar 27.
6
Mitoxantrone, etoposide and cytarabine following epigenetic priming with decitabine in adults with relapsed/refractory acute myeloid leukemia or other high-grade myeloid neoplasms: a phase 1/2 study.在复发/难治性急性髓系白血病或其他高级别髓系肿瘤成人患者中,地西他滨进行表观遗传预处理后使用米托蒽醌、依托泊苷和阿糖胞苷:一项1/2期研究
Leukemia. 2017 Dec;31(12):2560-2567. doi: 10.1038/leu.2017.165. Epub 2017 May 30.
7
Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel.成人急性髓系白血病的诊断与管理:2017年国际专家小组的欧洲白血病网络(ELN)建议
Blood. 2017 Jan 26;129(4):424-447. doi: 10.1182/blood-2016-08-733196. Epub 2016 Nov 28.
8
Efficacy and safety of decitabine in combination with G-CSF, low-dose cytarabine and aclarubicin in newly diagnosed elderly patients with acute myeloid leukemia.地西他滨联合粒细胞集落刺激因子、小剂量阿糖胞苷及阿柔比星治疗初诊老年急性髓细胞白血病的疗效与安全性
Oncotarget. 2015 Mar 20;6(8):6448-58. doi: 10.18632/oncotarget.3361.
9
Sequential treatment with cytarabine and decitabine has an increased anti-leukemia effect compared to cytarabine alone in xenograft models of childhood acute myeloid leukemia.与单独使用阿糖胞苷相比,阿糖胞苷和地西他滨序贯治疗在儿童急性髓系白血病的异种移植模型中具有更强的抗白血病作用。
PLoS One. 2014 Jan 28;9(1):e87475. doi: 10.1371/journal.pone.0087475. eCollection 2014.
10
Pretreatment of leukemic cells with low-dose decitabine markedly enhances the cytotoxicity of gemtuzumab ozogamicin.用低剂量地西他滨对白血病细胞进行预处理可显著增强吉妥珠单抗奥唑米星的细胞毒性。
Leukemia. 2013 Jan;27(1):233-5. doi: 10.1038/leu.2012.178. Epub 2012 Jul 3.