Actively Recruiting
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
Led by National Taiwan University Hospital · Updated on 2024-05-17
100
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In recent years, the goal of stopping drug therapy, also known as treatment-free remission (TFR), is emerging as one of the management goals of chronic myeloid leukemia (CML) therapy. Because there is no available data on Asian patients with CML undergoing tyrosine kinase inhibitor discontinuation (TKI), the investigators plan to recruit chronic phase CML patients with deep treatment response and good medical compliance in Taiwan to evaluate the feasibility, safety and clinical consequences of TKI discontinuation.
CONDITIONS
Official Title
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 years or older with chronic phase chronic myeloid leukemia (CP-CML)
- BCR-ABL fusion in the form of either e13a2 or e14a2 (p210)
- No documented resistance to second-generation tyrosine kinase inhibitors (Nilotinib or Dasatinib)
- At least 5 years of consecutive treatment with imatinib, or at least 4 years with a second-generation TKI (Nilotinib or Dasatinib)
- Achieved MR4.5 (BCR-ABL 8 0.0032% IS) or undetectable disease for at least 2 years, documented on at least 4 separate tests performed 3 months apart
- Access to a reliable qPCR-based BCR-ABL test sensitive to at least MR4.5
You will not qualify if you...
- Deemed ineligible by the study investigator after evaluation
- No intention to participate in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
W
Wen-Chien Chou, MD. PhD.
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
0
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