NCT07158294

Brief 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. 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Feb 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Apr 2029

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

August 28, 2025

Last Update Submit

August 28, 2025

Conditions

Chronic Myeloid Leukemia (CML)

Keywords

FailureDigital PCRBCR:ABL1 mutation

Outcome Measures

Primary Outcomes (1)

  • 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.

    At enrollment

Study Arms (1)

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.

Other: Peripheral blood withdrawal for BCR::ABL1 mutations testing

Interventions

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.

Evaluation of BCR::ABL1 KD mutations by ddPCR in CML patients resistant to TKI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simona Soverini

    Department of Medical and Surgical Sciences, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Bologna, Bologna, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

00390670390528p.fazi@gimema.it

Enrico Crea

CONTACT

00390670390514e.crea@gimema.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share