S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia
S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research trial studies bone marrow samples from women with acute myeloid leukemia.
研究概览
详细说明
OBJECTIVES:
- Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors.
- Explore whether there is an association between the cellular origin of AML (i.e., origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient characteristics.
- Explore whether overall survival (OS), event-free survival (EFS), disease-free survival (DFS), response rate (RR), or relapse rate is improved for patients with AMLs that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors compared to patients with clonally involved cells not detected.
OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. Results are then compared with each patient clinical data.
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
DISEASE CHARACTERISTICS:
- Diagnostic bone marrow specimens from female patients with untreated AML undergoing intensive ("3+7"-like) induction chemotherapy
- Specimens from the South Western Oncology Group (SWOG) protocols S0106 (age 18 to 60 years), excluding patients who received gemtuzumab ozogamicin (GO), and S9333 (age > 60 years)
PATIENT CHARACTERISTICS:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
学习计划
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 |
大体时间 |
---|---|
Association between CD33+ precursors and cytogenetic and/or molecular risks using Fisher's exact test
大体时间:May 2012
|
May 2012
|
Relationship between emergence of individual mutations [t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, and KIT], clonality, and stage of cell differentiation using Fisher's exact test
大体时间:May 2012
|
May 2012
|
Associations between survival outcomes (OS, EFS, DFS, RR, and relapse rate) and CD33+ restriction using regression analysis
大体时间:May 2012
|
May 2012
|
合作者和调查者
调查人员
- 首席研究员:Roland Walter, MD, PhD、Fred Hutchinson Cancer Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- 具有 11q23 (MLL) 异常的成人急性髓性白血病
- 伴有 inv(16)(p13;q22) 的成人急性髓性白血病
- 成人急性髓性白血病伴 t(16;16)(p13;q22)
- 成人急性髓性白血病伴 t(8;21)(q22;q22)
- 未经治疗的成人急性髓性白血病
- 成人急性巨核细胞白血病 (M7)
- 成人急性低分化髓性白血病 (M0)
- 成人急性单核细胞白血病 (M5a)
- 成人急性单核细胞白血病 (M5b)
- 成熟型成人急性成髓细胞白血病 (M2)
- 未成熟的成人急性成髓细胞白血病 (M1)
- 成人急性粒单核细胞白血病 (M4)
- 成人急性嗜碱性白血病
- 成人急性嗜酸性粒细胞白血病
- 成人红白血病 (M6a)
- 成人纯红细胞白血病 (M6b)
- 伴有 del(5q) 的成人急性髓性白血病
其他研究编号
- S0106B (其他标识符:SWOG)
- U10CA032102 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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