Clinical trial · Observational
Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia, BCR/ABL-Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The proportion of patients who were in major molecular response (MMR) without re-initiation of treatment
- timeFrame
- at week 48 of tyrosine kinase inhibitor (TKI) discontinuation
- description
- Real-time quantitative polymerase chain reaction (RT-qPCR) would be done to determined the transcript level of BCR-ABL fusion gene in peripheral blood samples
Secondary outcomes (5)
- measure
- The proportion of patients who were in MR4.5 (BCR-ABL transcript level ⩽0.0032% IS) and off treatment
- timeFrame
- at week 48 of TKI discontinuation
- description
- Real-time quantitative polymerase chain reaction (RT-qPCR) would be done to determined the transcript level of BCR-ABL fusion gene in peripheral blood samples
- measure
- Treatment-free survival
- timeFrame
- From the start of TKI discontinuation until the earliest occurrence of any of the following: loss of MMR, restart of TKI for any reason, progression to accelerated phase/blast phase, or death of any cause, assessed up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available