Status:
NOT_YET_RECRUITING
Identification of BCR::ABL1 Mutations by Digital PCR in CML
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Chronic Myeloid Leukemia (CML)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to asses the ability of digital PCR (ddPCR) to detect actionable mutations in adult CML patients with failure of TKI therapy. The main objective of the study is it aims to an...
Detailed Description
This is a multicenter biological study addressing the efficiency of ddPCR in detecting actionable mutations in patients with failure of TKI therapy. The study will involve 4 reference laboratories for...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07158294
Start Date
February 1 2026
End Date
April 1 2029
Last Update
September 5 2025
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