NCT04143087Unknown不适用
A Multicenter, Open-access Study of CML-CP Patients Treated With Effective TKIs at Least 5 Years and MR4.5(BCR/ABLIS<0.0032%) Maintenance More Than 18 Months Who Treatment With Half TKIs or Discontinue
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MMR(BCR/ABL IS<0.01) on 12 moth
研究概览
简要总结
Compare MMR on 12 month treated with half TKIs(including imatinib, dasatinib, and nilotinib) or TKIs withdrawal.
详细描述
- Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receive effective Tyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 5 years, and patients with BCR/ABLIS continuous negative in the last 18 months were randomly admitted to maintain the original effective TKI by half or stop taking .
- Q-pcr detected BCR/ABLIS in peripheral blood once every month, once every two months after half a year, and continuously monitored for 12 months.
- If the patients detected molecular recurrence (loss of MMR, BCR/ABLIS > 0.1%), the original dose of TKI should be administered again.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old, gender is not limited;
- •Diagnosed CML chronic phase and effective TKI(including imatinib, dasatinib, and nilotinib) was continued for more than 5 years
- •Q-PCR monitored BCR/ABLIS duration < 0.0032% in the last 18 months
- •Informed consent of the patient or his legal representative
排除标准
- •Patients had history of CML-AP or CML-BC
- •CML patients with previous or current ABL kinase mutations
- •CML Patients who have received allogeneic hematopoietic stem cell transplantation
- •CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
- •Woman who is pregnant or nursing
研究组 & 干预措施
Withdrawal TKIs
干预措施: withdrawal TKIs or halve TKIs (Drug)
halve TKIs
干预措施: withdrawal TKIs or halve TKIs (Drug)
结局指标
主要结局
MMR(BCR/ABL IS<0.01) on 12 moth
时间窗: 12 moth
Half dose TKIs or discontinue TKIs treatment
次要结局
未报告次要终点
研究者
xuna
Associate chief physician
Nanfang Hospital, Southern Medical University
研究点 (1)
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