S9031-9333-0106-0112-A Study of Biomarkers in Samples From Patients With Acute Myeloid Leukemia Treated With Standard Chemotherapy With or Without Gemtuzumab Ozogamicin
The Development of Predictive Biomarker Models for Patients Receiving Standard Induction Chemotherapy With and Without Gemtuzumab Ozogamicin
RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research trial studies biomarkers in samples from patients with acute myeloid leukemia treated with standard chemotherapy with or without gemtuzumab ozogamicin.
研究概览
详细说明
OBJECTIVES:
- To determine whether measuring biomarkers in less-differentiated acute myeloid leukemia (AML) blasts significantly improves their predictive accuracy to predict clinical outcomes for patients receiving induction/consolidation chemotherapy with and without gemtuzumab ozogamicin.
- To develop and validate novel predictive biomarker models for predicting clinical outcomes for AML patients receiving induction/consolidation chemotherapy with and without gemtuzumab ozogamicin.
OUTLINE: DNA and RNA extracted from archived bone marrow and peripheral blood samples are analyzed for genomic mutations (CEBPA, FLT3, IDH1/2, KIT, NPM1, RUNX1, TP53, and WT1) and transcriptional biomarkers (BAALC, CCNA1, CD34, CEBPA, ERG, EVI1, FLT3, IL3RA, MCL1 [two splice variants], MN1, RUNX1, and WT1) by PCR and real-time PCR. Data are then analyzed by the Gene Scan software.
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:
- Pretreatment bone marrow (BM) and peripheral blood (PB) samples obtained from Southwest Oncology Group ( SWOG) Leukemia Repository for adult patients enrolled on SWOG-9031, SWOG-9333, SWOG-S0106, and SWOG-S0112
- Samples restricted to those patients from these studies with at least 3 or more vials of remaining material in the SWOG Leukemia Repository and vials containing at least 1.5 x 10^7 cells/vial
- Samples from patients who received standard induction with cytarabine (ARA)/daunorubicin hydrochloride (DNR) with the addition of gemtuzumab ozogamicin (Mylotarg®) on one arm of S0106
PATIENT CHARACTERISTICS:
- Not specified
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 |
|---|---|
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Biomarker assays in highly purified populations of AML myeloblasts are more predictive of clinical outcomes as compared to the same tests examining unsorted cells
大体时间：immediate
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immediate
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Development of risk-assessment biomarker model for clinical outcomes
大体时间：immediate
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immediate
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合作者和调查者
调查人员
- 首席研究员：Derek L. Stirewalt, MD、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
其他研究编号
- S9031-9333-0106-0112-A (其他标识符：SWOG)
- U10CA032102 (美国 NIH 拨款/合同)
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