A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in… (NCT05341050) | Clinical Trial Compass
RecruitingNot Applicable
A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML
China260 participantsStarted 2022-04-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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