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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

About this trial

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.

Eligibility criteria

Qualifiers

molecularly confirmed diagnosis of BCR::ABL1+ CML;

positivity for either e13a2 or e14a2 transcript;

age ≥18 years;

chronic phase;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Peripheral blood withdrawal for BCR::ABL1 mutations testing

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

This trial has no locations