CML ADVOCATES NETWORK

Clinical Trials

ASC2ADHERE (CABL001J1DE02) = Asciminib in Adult Patients with Ph+ CML-CP [Germany]

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Study title

Tolerability, Safety and Effectiveness of Asciminib in Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase

Scientific title

A Non-Interventional Study on the Tolerability, Safety and Effectiveness of Asciminib in Newly Diagnosed and Pre-treated Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany – the ASC2ADHERE Study

Type of study

Observational study

Phase

Observational study

Current status

Recruiting

Other trial ID

ClinicalTrials.gov NCT07549516

What is the purpose of the study

The aim of this study is to assess the real-world effectiveness of asciminib in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) who were either newly diagnosed or previously treated with one tyrosine kinase inhibitor (TKI), including imatinib, dasatinib, bosutinib, or nilotinib.

What will happen during the study

Patients who have provided their written informed consent to participate in the study will be enrolled and followed up for 24 months to assess study outcomes.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years and older.
  • have a confirmed diagnosis of Ph+ CML-CP.
  • have either been newly diagnosed with Ph+ CML-CP or have been treated with exacty one prior TKI:
    • newly diagnosed patients who are currently receiving asciminib, imatinib, dasatinib, bosutinib or nilotinib.
    • patients who have received one prior TKI and are currently receiving asciminib according to the 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:

  • have contraindications to their respective CML treatment as per the applicable Prescribing Information and relevant national treatment guidelines.
  • are currently receiving or planned to receive asciminib or other TKIs outside the approved label.
  • are currently participating in an interventional clinical trial.
  • refuse to sign an informed consent.

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

Estimated primary completion date

September 2030

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

Germany

Bad Liebenwerda, 04924
Novartis Investigative Site

Berlin, 12487
Novartis Investigative Site

Bremerhaven, 27576
Novartis Investigative Site

Buchholz Nordheide, 21244
Novartis Investigative Site

Cologne, 50677
Novartis Investigative Site

Cottbus, 03046
Novartis Investigative Site

Detmold, 32756
Novartis Investigative Site

Hannover, 30625
Novartis Investigative Site

Munich, 81241
Novartis Investigative Site

Offenbach, 63065
Novartis Investigative Site

Parchim, 19370
Novartis Investigative Site

Potsdam, 14467
Novartis Investigative Site

Schorndorf, 73614
Novartis Investigative Site

Stade, 21680
Novartis Investigative Site

Zittau, 02763
Novartis Investigative Site