Overview
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.
Description
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
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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