NCT03647215已完成不适用
A Cohort Study To Establish the Prevalence of Mutations in Patients With CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ ALL With Detectable BCR-ABL Currently Being Treated With First or Subsequent TKI Therapy in the UK, Ireland, or France Using Next-Generation Sequencing
Incyte Biosciences UK33 个研究点 分布在 2 个国家目标入组 427 人开始时间: 2017年12月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 427
- 试验地点
- 33
- 主要终点
- Percentage of participants with any mutation
研究概览
简要总结
A multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are being treated with first or subsequent tyrosine kinase inhibitor (TKI) therapy in the UK, Ireland, or France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 18 years) with CML (in all phases of disease) or Ph+ ALL with detectable BCR-ABL levels who are being treated with a first or subsequent TKI.
- •Patients with CML must meet the warning or failure criteria as per the ELN guidelines for first second and subsequent treatment line, including:
- •BCR-ABL/ABL IS transcripts > 10% at 3 months
- •BCR-ABL/ABL IS transcripts > 1% at 6 months
- •BCR-ABL/ABL IS transcripts > 0.1% at 12 months or later
- •Patients with CML must not currently be in MMR (ie, have disease with BCR-ABL1/ABL1 transcripts > 0.1% IS).
- •Patients with Ph+ ALL with any level of BCR-ABL/ABL IS transcripts. Patients with Ph+ ALL should have BCR-ABL1/ABL1 transcript levels > 0.1% and should not be currently enrolled in UKALL14 but may have relapsed during or after participation in UKALL
- •Patients with an intermediate or high Sokal score (> 0.8) can be recruited into the study from 3 months after diagnosis, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months.
- •Patients with additional chromosomal abnormalities at diagnosis and patients with AP-CML may be recruited into the study, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months and beyond provided BCR-ABL1/ABL1 transcript levels are > 0.1% IS. It is recommended that these patients have mutational analysis performed every 3 months irrespective of BCR-ABL1/ABL1 transcript levels until they reach MR3/MMR (BCR-ABL1/ABL1 < 0.1% IS).
- •Any patients who have previously undergone testing for KD mutations, irrespective of KD mutational analysis test results.
- •Patients who have the ability to understand the requirements of the study and provide written informed consent.
排除标准
- •Patients without detectable BCR-ABL and patients who have switched TKI due to intolerance but who have met the criteria for optimal response (CP-CML, ELN 2013 guidelines).
结局指标
主要结局
Percentage of participants with any mutation
时间窗: Up to approximately 1 month per individual participant.
All samples will be processed by NGS.
Frequency of all specific mutations
时间窗: Up to approximately 1 month per individual participant.
All samples will be processed by NGS.
次要结局
- Frequency of individual mutations in Ph+ ALL(Up to approximately 1 month per individual participant.)
- Percentage of participants with individual mutations by whether a participant is intolerant or resistant to their previous TKI(Up to approximately 1 month per individual participant.)
- Percentage of participants with individual mutations by BCR-ABL level(Up to approximately 1 month per individual participant.)
- Percentage of participants with individual mutations in Ph+ ALL(Up to approximately 1 month per individual participant.)
- Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI(Up to approximately 1 month per individual participant.)
- Percentage of participants with individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML(Up to approximately 1 month per individual participant.)
- Frequency of individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML(Up to approximately 1 month per individual participant.)
- Frequency of individual mutations by BCR-ABL level(Up to approximately 1 month per individual participant.)
研究者
研究点 (33)
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