Chronic Myeloid Leukemia (CML)DiP-in-CMLNCT07158294
Identification of BCR::ABL1 Mutations by Digital PCR in CML
A study testing Peripheral blood withdrawal for BCR::ABL1 mutations testing in people with Chronic Myeloid Leukemia (CML), run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- What is being tested?
- Peripheral blood withdrawal for BCR::ABL1 mutations testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Digital PCR for Deep Sensitivity BCR::ABL1 Mutation Screening 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.
Read the detailed description
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.
- Conditions
- Chronic Myeloid Leukemia (CML)
- Being tested
- Peripheral blood withdrawal for BCR::ABL1 mutations testing
- Keywords
- Failure, Digital PCR, BCR:ABL1 mutation
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood withdrawal for BCR::ABL1 mutations testingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of BCR::ABL1 KD mutations by ddPCR in CML patients resistant to TKI | Other | Peripheral blood withdrawal for the analysis of BCR::ABL1 KD mutations by ddPCR. DdPCR results will be compared with NGS results. Receives: Other: Peripheral blood withdrawal for BCR::ABL1 mutations testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Soverini, Principal investigator, Department of Medical and Surgical Sciences, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Bologna, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158294
- Sponsor's protocol ID
- CML1725
- Acronym
- DiP-in-CML
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital PCR for Deep Sensitivity BCR::ABL1 Mutation Screening in CML
- ClinicalTrials.gov ID
- NCT07158294
- Acronym / sponsor ID
- DiP-in-CML / CML1725
- Conditions
- Chronic Myeloid Leukemia (CML)
- Keywords
- Failure, Digital PCR, BCR:ABL1 mutation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of BCR::ABL1 KD mutations by ddPCR in CML patients resistant to TKI | Other | Other: Peripheral blood withdrawal for BCR::ABL1 mutations testingPeripheral blood withdrawal for the analysis of BCR::ABL1 KD mutations by ddPCR. DdPCR results will be compared with NGS results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood withdrawal for BCR::ABL1 mutations testingPeripheral 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. | Other | Evaluation of BCR::ABL1 KD mutations by ddPCR in CML patients resistant to TKI |
Primary outcome
Mutations detected by ddPCR
Time frame: At enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simona Soverini principal investigator
Department of Medical and Surgical Sciences, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Bologna, Bologna, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral blood withdrawal for BCR::ABL1 mutations testing in people with Chronic Myeloid Leukemia (CML), run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (00390670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutations detected by ddPCR (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.