An interventional study of Peripheral blood withdrawal for BCR::ABL1 mutations testing in Chronic Myeloid Leukemia (CML), sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Not applicable, Interventional, and Screening
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.
This is a multicenter biological study addressing the efficiency of ddPCR in detecting actionable mutations in patients with failure of TKI therapy. The study will involve 4 reference laboratories for BCR::ABL1 KD mutation testing Italian hematological centers enrolling patients and collecting samples for analysis.
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 generated by reference laboratories belonging to LabNet CML network . 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.
No modification of TKI type or TKI dose will be performed on the basis of ddPCR results.
964 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's planned enrollment of 150 is above the median of 44 across 743 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 132 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Peripheral blood withdrawal for the analysis of BCR::ABL1 KD mutations by ddPCR. DdPCR results will be compared with NGS results.
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.
Mutations detected by ddPCR
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.
Time frame: At enrollment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive→
Gruppo Italiano Malattie EMatologiche dell'Adulto