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Active, not recruiting Observational

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

NCT06092879 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-03-06
Last updated
2026-05-29

Condition(s) studied

Chronic Myeloid Leukemia

Investigational drug(s) / intervention(s)

Asciminib

Asciminib: There is no treatment allocation. Patients administered Asciminib by prescription will be enrolled

Study summary

The purpose of this study is to enhance the knowledge on asciminib treatment in a broader and real-life population by collecting additional data to characterize the treatment patterns of patients treated with asciminib, with a primary objective represented by maintenance on treatment at 12 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of patients remaining on asciminib at 12 months — Month 12
    Proportion of patients remaining on asciminib treatment at 12 months to be provided

Trial sites (52)

FacilityCityRegionStatus
Novartis Investigative Site Angers France
Novartis Investigative Site Limoges Haute Vienne
Novartis Investigative Site Saint Priest Jarez Pays de la Loire Region
Novartis Investigative Site Aix-en-Provence France
Novartis Investigative Site Amiens France
Novartis Investigative Site Antibes France
Novartis Investigative Site Avignon France
Novartis Investigative Site Besançon France
Novartis Investigative Site Bobigny France
Novartis Investigative Site Bordeaux France
Novartis Investigative Site Bordeaux France
Novartis Investigative Site Brest France
Novartis Investigative Site Brive-la-Gaillarde France
Novartis Investigative Site Caen France
Novartis Investigative Site Cagnes-sur-Mer France
Novartis Investigative Site Cannes France
Novartis Investigative Site Castelnau-le-Lez France
Novartis Investigative Site Cesson-Sévigné France
Novartis Investigative Site Chambéry France
Novartis Investigative Site Clermont-Ferrand France
Novartis Investigative Site Corbeil-Essonnes France
Novartis Investigative Site Dunkirk France
Novartis Investigative Site Essey-lès-Nancy France
Novartis Investigative Site Grenoble France
Novartis Investigative Site Le Kremlin-Bicêtre France
Novartis Investigative Site Le Mans France
Novartis Investigative Site Lens France
Novartis Investigative Site Libourne France
Novartis Investigative Site Lorient France
Novartis Investigative Site Lyon France
Novartis Investigative Site Montpellier France
Novartis Investigative Site Montpellier France
Novartis Investigative Site Mulhouse France
Novartis Investigative Site Nantes France
Novartis Investigative Site Nevers France
Novartis Investigative Site Nîmes France
Novartis Investigative Site Paris France
Novartis Investigative Site Paris France
Novartis Investigative Site Paris France
Novartis Investigative Site Perpignan France

+ 12 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06092879 on ClinicalTrials.gov ↗ ← All trials in France