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

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. The presence of the Ph+ chromosome may alternatively be confirmed by molecular detection of a BCR::ABL1 fusion gene/transcript, in accordance with the World Health Organization (WHO) 2022 classification.
• 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, as well as additional disease- or treatment-related characteristics associated with distinct clinical scenarios that differ from the intended study population.
• 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

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 centers / principal investigators

Germany

Novartis Investigative Site
Aschaffenburg, 63739

Novartis Investigative Site
Augsburg, 86152

Novartis Investigative Site
Baden-Baden, 76532

Novartis Investigative Site
Bad Friedrichshall, 74177

Novartis Investigative Site
Bad Liebenwerda, 04924

Novartis Investigative Site
Berlin, 10559

Novartis Investigative Site
Berlin, 12487

Novartis Investigative Site
Bremerhaven, 27568

Novartis Investigative Site
Bremerhaven, 27576

Novartis Investigative Site
Buchholz Nordheide, 21244

Novartis Investigative Site
Cottbus, 03046

Novartis Investigative Site
Detmold, 32756

Novartis Investigative Site
Donauwörth, 86609

Novartis Investigative Site
Dorfen, 84405

Novartis Investigative Site
Dortmund, 44363

Novartis Investigative Site
Dresden, 01307

Novartis Investigative Site
Düren, 52353

Novartis Investigative Site
Erfurt, 99085

Novartis Investigative Site
Göttingen, 37073

Novartis Investigative Site
Hannover, 30161

Novartis Investigative Site
Hannover, 30625

Novartis Investigative Site
Heidenheim, 89522

Novartis Investigative Site
Herrsching am Ammersee, 82211

Novartis Investigative Site
Hildesheim, 31135

Novartis Investigative Site
Kassel, 34125

Novartis Investigative Site
Kempten (Allgäu), 87439

Novartis Investigative Site
Kiel, 24105

Novartis Investigative Site
Köln, 50674

Novartis Investigative Site
Köln, 50677

Novartis Investigative Site
Landsberg am Lech, 86899

Novartis Investigative Site
Leipzig, 04103

Novartis Investigative Site
Leverkusen, 51375

Novartis Investigative Site
Merseburg, 06217

Novartis Investigative Site
Munich, 81241

Novartis Investigative Site
Mutlangen, 73557

Novartis Investigative Site
Naunhof, 04683

Novartis Investigative Site
Neuss, 41462

Novartis Investigative Site
Offenbach, 63065

Novartis Investigative Site
Offenburg, 77654

Novartis Investigative Site
Oldenburg in Holstein, 23758

Novartis Investigative Site
Oldenburg, 26121

Novartis Investigative Site
Parchim, 19370

Novartis Investigative Site
Potsdam, 14467

Novartis Investigative Site
Potsdam, 14482

Novartis Investigative Site
Regensburg, 93053

Novartis Investigative Site
Rotenburg (Wümme), 27356

Novartis Investigative Site
Saalfeld, 07318

Novartis Investigative Site
Schorndorf, 73614

Novartis Investigative Site
Schwäbisch Hall, 74523

Novartis Investigative Site
Soest, 59494

Novartis Investigative Site
Solingen, 42653

Novartis Investigative Site
Stade, 21680

Novartis Investigative Site
Twistringen, 27239

Novartis Investigative Site
Wesel, 46483

Novartis Investigative Site
Winnenden, 71364

Novartis Investigative Site
Zittau, 02763