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Transfusion in Adult Acute Myeloid Leukemia

2016年9月8日 更新者:Hospices Civils de Lyon

Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukemia

Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.

Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.

Based on these data, we retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

1067

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

An observational, longitudinal, and retrospective study was conducted in 1067 patients (>15 years of age) fulfilling the clinical and laboratory criteria for diagnosis of AML. Patients were admitted at the Lyon University Hospital over two decades (fromMarch 1985 to December 2006) and enrolled onto 12 successive therapeutic trials according to age and time of enrollment. Diagnosis of AML was based on smears of bone marrow aspirates. Leukemic cells were classified according to the French-American-British (FAB) criteria. FAB M3 AMLs were not included in the study. AML with 20 % or more myeloid marrow blasts, either de novo or evolving from a MDS, was eligible in the absence of (i)World Health Organization (WHO) performance status >2; (ii) left ventricular systolic ejection fraction below the normal range; (iii) a creatinine or hepatic enzyme levels >2 ULN, except ifAML-related; and (iv) uncontrolled severe infection. All participants gave their written informed consent

描述

Inclusion Criteria:

  • Patient > 15 years old
  • Newly diagnosed AML or post myelodysplastic syndrome (MDS)

Exclusion Criteria:

  • Patients with M3 AML of FAB classification (APL, Acute Promyelocytic Leukemia)
  • World Health Organization (WHO) performance status >2;
  • Left ventricular systolic ejection fraction below the normal range
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Serum creatinine concentration > 2x ULN (Upper Limit of Normal laboratory ranges),
  • AST or ALT levels > 2.0 x ULN, except if AML-related

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall survival (OS)
大体时间:3 year OS
Overall survival (OS) is defined as the time elapsed between induction chemotherapy regimen and death for any cause. Patients not known to have this event are censored on the date they were last examined
3 year OS
Overall survival (OS)
大体时间:7 year OS
Overall survival (OS) is defined as the time elapsed between induction chemotherapy regimen and death for any cause. Patients not known to have this event are censored on the date they were last examined
7 year OS

次要结果测量

结果测量
措施说明
大体时间
Complete remission (CR) rate
大体时间:Up to 10 weeks
Response to induction therapy was assessed after one or two courses of chemotherapy. CR was defined according to standard criteria as less than 5 % blasts in bone marrow aspirates with evidence of maturation of cell lines and restoration of peripheral blood counts
Up to 10 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年1月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2015年7月1日

研究注册日期

首次提交

2016年8月25日

首先提交符合 QC 标准的

2016年9月8日

首次发布 (估计)

2016年9月14日

研究记录更新

最后更新发布 (估计)

2016年9月14日

上次提交的符合 QC 标准的更新

2016年9月8日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

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