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临床试验/NCT02034656
NCT02034656Unknown不适用

Patterns of ABL Mutation in Asian With Imatinib Resistant Chronic Myeloid Leukemia and Ph Positive Acute Lymphocytc Leuekmia Patients (AMICA): A Retrospective Feasibility Study

Seoul St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
125
试验地点
1
主要终点
Analyzing the patterns and rate of BCR-ABL mutations in Asian CML and Ph positive ALL patients

研究概览

简要总结

The purposes of this study are to investigate the patterns of BCR-ABL mutations in CML and Ph positive ALL patients with imatinib resistance during the year of 2001-2009 in Asian institutes.

详细描述

Awareness of the significance of BCR-ABL mutations is generally low across Asia. This is partly due to historical limitations in capabilities for mutation testing. While numerous mutation studies have been done in non-Asian populations, there are very few published reports on mutations in Asians. CML management in Asia therefore continues to be largely intuitive.

Anecdotal reports, suggest that there may differences in the presence or absence of mutations at the time of initial diagnosis and their occurrence during imatinib treatment. At present, however, we have no comprehensive formal knowledge of the actual nature of mutations in Asians. There are moves towards the establishment of CML registries that will capture the pattern of mutations among Asian patients.

In recent years, several laboratories in the region have been performing mutation analysis. However, no systematic evaluation of or report on these data has been undertaken. This study therefore intends to collect documented mutation data in Asian CML and Ph positive ALL patients from identified Asian institutes. While this is a retrospective, cross-sectional analysis of mutation information, the study will provide the first comprehensive formal report on mutations in Asian CML and Ph positive ALL patients. The collecting information has the potential better to inform the clinical management of CML and Ph positive ALL in Asia according to the mutation result and possibly future research in these patients.

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

  • All mutation data from CML and Ph positive ALL patients who developed imatinib resistance during the year 2001-2009

排除标准

  • Mutation data from CML and Ph positive ALL patients who, in addition to imatinib, received other therapy. Follow up mutation report after second generation TKI therapy.

结局指标

主要结局

Analyzing the patterns and rate of BCR-ABL mutations in Asian CML and Ph positive ALL patients

时间窗: 9 years

To describe the patterns and rate of BCR-ABL mutations in Asian CML and Ph positive ALL patients. To compare the patterns of BCR-ABL mutations to that of Non-Asian. To describe methods used in mutation analysis

次要结局

  • Description of the choice of second-line therapy(9 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong-Wook Kim

Professor

Seoul St. Mary's Hospital

研究点 (1)

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