Status:
RECRUITING
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Chronic Myeloid Leukemia, BCR/ABL-Positive
Eligibility:
All Genders
20+ years
Brief Summary
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...
Detailed Description
1\. Primary goal: To evaluate the feasibility, safety and clinical consequences of TKI discontinuation in chronic phase CML(CP-CML) patients with deep treatment response and good medical compliance in...
Eligibility Criteria
Inclusion
- The participant should be an adult (age ⩾20 years) with CP-CML.
- The BCR-ABL fusion should be in the form of either e13a2 or e14a2 (p210)
- The participant should not have documented resistance to a 2nd-generation TKI (Nilotinib or Dasatinib)
- 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)
- 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.
- Access to a reliable qPCR-based BCR-ABL test with a sensitivity of detecting of at least MR4.5.
Exclusion
- After evaluation, the participant is deemed to be ineligible by the investigator of this study.
- The participant has no intention to be recruited into this study.
Key Trial Info
Start Date :
August 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 11 2032
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05439889
Start Date
August 11 2022
End Date
August 11 2032
Last Update
May 17 2024
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 10002