CML ADVOCATES NETWORK

Clinical Trials

ASSURE-3 (CABL001AFR04) = Asciminib in Real World Setting [France]

Study title

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

Scientific title

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

Type of study

Observational study

Phase

Observational study

Current status

Recruiting

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Other trial ID

ClinicalTrials.gov NCT06092879

What is the purpose of the study

This is a study to better understand treatment with asciminib in a real-world setting.

What will happen during the study

Data will be collected on the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKI). Patients will be followed for 15 months or until premature discontinuation of asciminib treatment.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years or older.
  • have Ph+ CML-CP previously treated with two or more tyrosine kinase inhibitors (TKI).
  • are going to be treated with asciminib as determined by the treating physician (investigator) according to their own practice, the locally approval label / Summary of Product Characteristics (SmPC), and regardless of study participation.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have CML in accelerated phase (AP) or blastic phase (BP) at enrolment.
  • have a known history of T315I mutation.
  • previously received asciminib treatment.
  • are currently participating in an interventional clinical trial.
  • meet any of the known contraindications to asciminib according to the SmPC.
  • receive or are going to receive any investigational medicine during the observation period.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

December 2026

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov, This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Study Director, Novartis Pharmaceuticals

Principal investigator

Study centers / principal investigators

France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Mulhouse cedex, 68070