Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT07158294
Eligibility Criteria:
Inclusion Criteria:
* molecularly confirmed diagnosis of BCR::ABL1+ CML;
* positivity for either e13a2 or e14a2 transcript;
* age ≥18 years;
* chronic phase;
* on therapy with imatinib or 2 GTKIs (dasatinib, nilotinib and bosutinib);
* candidate to TKI switch because of resistance according to the ELN recommendations OR with a confirmed warning response to 2GTKI therapy according to the ELN recommendations;
* Signed written informed consent according to ICH/EU/GCP and national local laws.
Exclusion Criteria:
* blastic phase;
* Previous allogeneic transplant or candidate to allogeneic transplant;
* on treatment with ponatinib or asciminib, investigational TKIs or non-TKI-therapy;
* switch performed or planned due to intolerance and not to resistance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07158294
Study Brief:
Protocol Section:
NCT07158294