Status:
RECRUITING
A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML
Lead Sponsor:
xuna
Conditions:
MMR on 12 Month
Eligibility:
All Genders
18+ years
Brief 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 f...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT05341050
Start Date
April 1 2022
End Date
May 31 2026
Last Update
April 22 2022
Active Locations (2)
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1
NanfangH
Guangzhou, Guangdong, China, 510515
2
NanfangH
Guangzhou, Guangdong, China