CML ADVOCATES NETWORK

Clinical Trials

ASC4REAL (CABL001ASA01) = Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib [Saudi Arabia]

Study title

Prospective Study of the Effectiveness, Tolerability and Adherence of Asciminib in Saudi Arabia

Scientific title

Real-World Evidence Non-interventional Prospective Study for the Effectiveness, Tolerability and Adherence of Asciminib After Two Previous TKIs in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) in Saudi Arabia. (ASC4REAL)

Type of study

Observational study

Phase

Observational study

Current status

Recruiting

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Other trial ID

ClinicalTrials.gov NCT06684964

What is the purpose of the study

This is an observational study to assess the effectiveness and tolerability of asciminib in patients with chronic myeloid leukemia in chronic phase who were previously treated with 2 or more tyrosine kinase inhibitor (TKIs) in routine clinical practice in Saudi Arabia. The study also assesses patient adherence to and patient-reported outcomes of treatment with asciminib.

What will happen during the study

Patients who have been receiving asciminib for up to 6 months prior to study start will be enrolled over a period of approximately 6 months and followed up for 12 months to assess study outcomes.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years and older.
  • have laboratory values as specified in the study protocol.
  • have been diagnosed with Philadelphia chromosome positive (Ph+) CML in chronic phase (CP) and have been treated with 2 or more TKIs
  • are currently receiving asciminib according to locally approval label.
  • are willing to provide written informed consent prior to study enrollment.

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

Key exclusion criteria

This study does not include patients who:

  • are currently receiving asciminib treatement in first or second line.
  • are currently participating in any other clinical trials.
  • refuse to sign an informed consent.

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

Estimated primary completion date

July 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.
You can also find a study description on the website of Novartis.

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Study Director: Novartis Pharmaceuticals

Study centers / principal investigators

Saudi Arabia

Novartis Investigative Site
Jeddah, 21423

Novartis Investigative Site
Riyadh, 11426