NCT07158294Not yet recruiting
Identification of BCR::ABL1 Mutations by Digital PCR in CML
Digital PCR for Deep Sensitivity BCR::ABL1 Mutation Screening in CML
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Feb 2029
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT07158294
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Feb 2026 to the primary completion date, 1 Feb 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous allogeneic transplant or candidate to allogeneic transplant;
- on treatment with ponatinib or asciminib, investigational TKIs or non-TKI-therapy;
Other
- blastic phase;
- switch performed or planned due to intolerance and not to resistance.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.