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临床试验/NCT02899767
NCT02899767已完成不适用

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

Hospices Civils de Lyon0 个研究点目标入组 1,067 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,067
主要终点
Overall survival (OS)

研究概览

简要总结

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Overall survival (OS)

时间窗: 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

次要结局

  • Complete remission (CR) rate(Up to 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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