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

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 answer is to assess whether ddPCR is at least as effective as NGS in detecting actionable (2GTKI-resistant) mutations. To accomplish this aim, samples of participants treated according to clinical practice, will be taken and analyzed for the presence of BCR::ABL1 KD mutations by ddPCR.

NCT Number	NCT07158294
Lead Sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions	Chronic Myeloid Leukemia (CML)
Enrollment	150 participants
Start Date	2026-02-01
Primary Completion	2029-02-01 (estimated)
Study Completion	2029-04-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-05