NCT05439889Recruiting
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
Source: ClinicalTrials.gov · Last updated 17 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 15 Jun 2022
- Start date
- Aug 2022
- Primary completion date
- Aug 2028
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT05439889
What you commit to
- Study type: Observational
- Planned participants: 100
- From Aug 2022 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.