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Using asciminib to treat chronic myeloid leukemia in adults in France

Scemblix® (Asciminib): Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML-CP in Real World Setting in France

Observational Novartis · NCT06092879

This study is trying to see how well asciminib works for adults in France with chronic myeloid leukemia who have already been treated with other medications.

Quick facts

Study typeObservational
Enrollment168 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsasciminib
Locations38 sites (Saint Priest en Jarez, Loire and 37 other locations)
Trial IDNCT06092879 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world data on the treatment patterns of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase who have been previously treated with two or more Tyrosine Kinase Inhibitors. Conducted across multiple centers in France, the study will follow patients for 15 months to assess maintenance on asciminib treatment at 12 months. Data will be collected through electronic case report forms, including both historical and primary data from routine clinical visits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Philadelphia chromosome-positive chronic myeloid leukemia who have been treated with two or more Tyrosine Kinase Inhibitors.

Not a fit: Patients with chronic myeloid leukemia in accelerated or blastic phase, those with a history of T315I mutation, or those previously treated with asciminib will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of asciminib as a treatment option for patients with chronic myeloid leukemia.

How similar studies have performed: Other studies have shown success with similar observational approaches in chronic myeloid leukemia, indicating potential for valuable findings in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient aged ≥ 18 years at inclusion,
2. Patient with Ph+ CML-CP previously treated with two or more TKIs,
3. Patient for whom a decision has been taken by the treating physician (investigator) to initiate treatment with asciminib according to his own practice, the drug label / Summary of Product Characteristics (SmPC), and regardless of study participation,
4. Patient having given their non objection to participate to the study

Exclusion Criteria:

1. Patient with CML in accelerated phase (AP) or blastic phase (BP) at enrolment,
2. Patient with known history of T315I mutation,
3. Patient who previously received asciminib treatment,
4. Patient currently participating to an interventional clinical trial,
5. Patient with known contra-indication to asciminib according to the SmPC.

Where this trial is running

Saint Priest en Jarez, Loire and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Myeloid LeukemiaChronic myeloid leukemiaCMLasciminibFrance
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.