Clinical trial · Interventional
Identification of BCR::ABL1 Mutations by Digital PCR in CML
Digital PCR for Deep Sensitivity BCR::ABL1 Mutation Screening in CML
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral blood withdrawal for BCR::ABL1 mutations testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Evaluation of BCR::ABL1 KD mutations by ddPCR in CML patients resistant to TKI
- description
- Peripheral blood withdrawal for the analysis of BCR::ABL1 KD mutations by ddPCR. DdPCR results will be compared with NGS results.
- interventionNames
- Other: Peripheral blood withdrawal for BCR::ABL1 mutations testing
Primary outcomes (1)
- measure
- Mutations detected by ddPCR
- timeFrame
- At enrollment
- description
- The rate of actionable (2GTKI-resistant) mutations detectable by ddPCR as compared to NGS in patients with failure of TKI therapy according to the current (2020) ELN recommendations.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available