Follow-up Study of Stopping Drug Therapy in Chronic Myeloid Leukemia
Studies whether stopping leukemia drug therapy is feasible and safe in patients with deep response.
Plain-language title generated from the registry record
Registry title: Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
Key facts
- Where
- Taipei, TaiwanSee the site
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT05439889
- Record updated
- 17 May 2024
- Original description
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.Read full original descriptionShow less
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
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.
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.