Identification of BCR::ABL1 Mutations by Digital PCR in CML

NANot yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

February 1, 2026

Primary Completion Date

February 1, 2029

Study Completion Date

April 1, 2029

Conditions
Chronic Myeloid Leukemia (CML)
Interventions
OTHER

Peripheral blood withdrawal for BCR::ABL1 mutations testing

Peripheral blood samples taken from patients treated according to clinical practice with resistance to imatinib or 2GTKI therapy according to the ELN recommendations will be shipped to one of the reference laboratories and analyzed by ddPCR using Bio-Rad ADS assays and reagents. Samples will be analyzed in batches of suitable size. ddPCR results will be compared with NGS results. In patients positive for mutations below 20% by ddPCR (low level mutations) peripheral blood sample(s) will be collected every 3 months at subsequent follow-up visits to monitor the kinetics of mutations in relation to therapy continuation or change.

All Listed Sponsors
lead

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

NCT07158294 - Identification of BCR::ABL1 Mutations by Digital PCR in CML | Biotech Hunter | Biotech Hunter