Actively Recruiting
A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML
Led by xuna · Updated on 2022-04-22
260
Participants Needed
2
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female over 18 years
- Diagnosed with Philadelphia chromosome-positive (or PCR-positive BCR-ABL) chronic myeloid leukemia in chronic phase
- Treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years
- Maintained major molecular response (BCR/ABL IS <0.1%) for at least 2 years
- At least three recent molecular tests confirming MMR within past 24 months
- Signed informed consent
You will not qualify if you...
- Presence or history of T315I mutation
- Presence of rare unquantifiable atypical transcripts
- Comorbid cardiovascular disease or history of severe cardiovascular disease
- History of accelerated or blast phase or suspected blast disease
- Previous allogeneic hematopoietic stem cell transplantation
- Severe abnormal liver or kidney function (e.g., ALT above normal limit, AST >3 times normal, GFR <50%)
- Other tumors or history of malignancies with ECOG score >3
- Two-line abnormality in blood routine examination
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
NanfangH
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
2
NanfangH
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
xu na
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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