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Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission

Recruitingn/aAges 20 Years - anyAllNational Taiwan University Hospital
NCT05439889 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. The participant should be an adult (age ⩾20 years) with CP-CML. 2. The BCR-ABL fusion should be in the form of either e13a2 or e14a2 (p210) 3. The participant should not have documented resistance to a 2nd-generation TKI (Nilotinib or Dasatinib) 4. The participant should have received ≥ 5 years of consecutive treatment with imatinib, or ≥ 4 years of consecutive treatment with a 2nd-generation TKI (Nilotinib or Dasatinib) 5. The participant should have achieved MR4.5 (BCR-ABL ⩽0.0032% IS) or undetectable disease in the peripheral blood or bone marrow, for ≥ 2 years, which is documented on ≥ 4 separate tests performed ≥ 3 months apart. 6. Access to a reliable qPCR-based BCR-ABL test with a sensitivity of detecting of at least MR4.5. Exclusion Criteria: 1. After evaluation, the participant is deemed to be ineligible by the investigator of this study. 2. The participant has no intention to be recruited into this study.
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What it tests

  • Not listed
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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