This Study is a Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Drug Discontinuation After Dose Reduction in Ph+CML-CP Patients Threated With 2G-TKI.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- MMR(BCR/ABL IS<0.1%) on 24 months
研究概览
简要总结
patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be treated with halved dose for 12 months, and then stop for 12 months.
详细描述
1.Patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years.
2。During the TKI reduction phase, the peripheral blood BCR/ABLIS was detected by Q-PCR every two months and continuously monitored for 12 months. In the TFR period, the peripheral blood BCR/ABLIS was detected once a month for the first 6 months; the peripheral blood BCR/ABLIS was detected once every two months for the next 6 months; after that, the peripheral blood BCR/ABLIS was detected once every three months.
3.If the patients detected molecular recurrence (loss of MMR, BCR/ABL IS>0.1%),the original dose of 2G-TKI should be administered
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
- •Male or female over 18 years
- •Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP
- •Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years
- •Patients have maintained MMR (BCR/ABL IS<0.1% or more) at least 2 years
- •in the past 24 months, at least three times recent molecular reactions have confirmed MMR
- •Patients have signed the informed consent
排除标准
- •patients with the presence or history of T315I mutation
- •patients with the presence of rare unquantifiable atypical transcripts
- •Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease
- •patients have history of accelerated or blast phase, or suspected blast disease
- •patients have received allogeneic hematopoietic stem cell transplantation
- •patients have severe abnormal liver and kidney function (ALT > upper limit of normal, AST > 3 times normal upper line, glomerular filtration rate < 50%)
- •patients combined with other tumors or a history of other malignancies ECOG score>3
- •Two-line abnormality in the patient's blood routine examination
- •women is pregnant or nursing
研究组 & 干预措施
patients with Ph+ CML-CP
干预措施: TKI (Drug)
结局指标
主要结局
MMR(BCR/ABL IS<0.1%) on 24 months
时间窗: 24 months
Continue to treat patients at half-dose for 12 months, then stop for 12 months
次要结局
- MRFS(24 months)
研究者
xuna
Associate chief physician
Nanfang Hospital, Southern Medical University