Evaluating treatment-free remission in chronic myeloid leukemia patients
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
This study is testing if adults with chronic myeloid leukemia can safely stop their medication after achieving strong treatment results for at least two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | Nilotinib, Dasatinib, imatinib |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05439889 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older with chronic phase CML who have achieved a deep treatment response and have been compliant with their treatment.
Not a fit: Patients who have documented resistance to second-generation TKIs or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable a significant number of CML patients to safely discontinue their medication without disease relapse.
How similar studies have performed: While there is limited data on Asian patients, similar studies in other populations have shown promising results regarding TKI discontinuation and treatment-free remission.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Taipei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.