Evaluating treatment-free remission in chronic myeloid leukemia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the feasibility, safety, and clinical outcomes of discontinuing tyrosine kinase inhibitor (TKI) therapy in chronic phase chronic myeloid leukemia (CML) patients who have achieved deep treatment responses. Participants will undergo regular molecular monitoring of BCR-ABL transcript levels after stopping TKI therapy to ensure safety and detect any loss of major molecular response. The study focuses on adult patients in Taiwan who have maintained a deep treatment response for at least two years. The findings could provide valuable insights into the management of CML and the potential for treatment-free remission.

Why it matters

Who can join: the full rules

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.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Wen-Chien Chou, MD. PhD.
• Email: wchou@ntu.edu.tw
• Phone: +886-2312-3456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.