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临床试验/NCT06429670
NCT06429670已完成不适用

Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory Settings: a Multicentric Study From French AURAML Group

Hospices Civils de Lyon12 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
12
主要终点
Overall survival

研究概览

简要总结

Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. However, AZA/VEN is also associated with an increased hematological toxicity compared to azacytidine alone. In this context, alternative AZA/VEN regimens emerged progressively based on each physician experience and local procedures. Moreover, AZA/VEN is also recognized as a valuable therapeutic option in relapse/refractory settings. In this multicentric study, the investigators aimed to evaluate the efficacy and safety of various AZA/VEN regimen in frontline and relapse/refractory (R/R) patients diagnosed with AML in real life setting.

The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers (Saint-Etienne, Clermont-Ferrand, Lyon (Hopital Lyon Sud, Centre Léon Bérard), Vichy, Annecy, Chambery, Valence, Bourgoin-Jallieu, Grenoble, Roanne) in Auvergne Rhône Alpes (AURA) region, between January 2019 and December 2023. Composite complete remission was defined as in VIALE-A trial. Measurable residual disease (MRD) negativity was defined as ≤ 10-3 by flow cytometry (on bone marrow) and/or ≤ 10-4 for NPM1 by RT-qPCR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years old
  • Acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or MRD relapse.
  • receiving AZA/VEN combination regimen

排除标准

  • Another VEN combination chemotherapy
  • AZA/VEN initiation prior January 2019 and after December 2023
  • Opposition to the study

结局指标

主要结局

Overall survival

时间窗: up to 5 months

Overall survival corresponds to time to death from the initiaiton of AZA/VEN, regardless of disease recurrence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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