A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany

Recruiting now

Conditions studied: Leukemia, Chronic Myeloid

In brief

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

Key facts

Study ID

NCT07549516

Run by

Novartis Pharmaceuticals

People needed

380

Starts

2026-04-17

Expected to finish

2030-09-30

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who provide written informed consent to participate in the study.
• Adult patients (≥18 years of age) with a confirmed diagnosis of Ph+ CML-CP.
• Patients who are either newly diagnosed or have received treatment with exactly one prior TKI. Prior TKI treatment is only permitted for patients in the Asciminib Cohort. Patients in the comparator cohorts (imatinib, dasatinib, bosutinib, nilotinib) must be newly diagnosed and must not have received any prior TKI treatment.
• Patients for whom the treating physician has made a clinical decision to initiate treatment with asciminib or another TKI (imatinib, dasatinib, bosutinib, nilotinib) as part of routine care. The clinical decision for treatment must have been made prior to enrollment. Treatment must not have started more than 14 days before study inclusion, and treatment may also begin after baseline assessment.
• Patients willing to participate in routine follow-up visits and complete patient-reported outcome questionnaires over the course of the study.

You may not qualify if…

• Patients with contraindications to their respective chronic myeloid leukemia (CML) treatment as per the applicable Summary of Product Characteristics (SmPC) and relevant national treatment guidelines (e.g. Onkopedia CML), including the following asciminib specific considerations:
• In first- or second-line treatment: presence of BCR::ABL1 fusion transcripts lacking exon a2 (e.g. e13a3, e14a3).
• In second-line treatment: known BCR::ABL1 mutations associated with partial or complete resistance to asciminib (e.g. M244V, F359I/V/C;T315I).
• Patients receiving or planned to receive asciminib or other TKIs outside the approved label (off-label use), including use in unapproved dosing regimens or frequency not covered by the respective SmPC.
• Patients currently participating in an interventional clinical trial.
• Patients unable or unwilling to provide written informed consent.
• Patients who are unable to reliably complete patient-reported outcome questionnaires due to cognitive or language limitations relevant to the study assessments.
• Patients for whom long-term follow-up is not feasible due to expected relocation or other logistical constraints.

Where it is running

• Novartis Investigative Site — Heidenheim, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Schwäbisch Hall, Baden-Wurttemberg, Germany (enrolling)
• Novartis Investigative Site — Aschaffenburg, Bavaria, Germany (enrolling)
• Novartis Investigative Site — Augsburg, Bavaria, Germany (enrolling)
• Novartis Investigative Site — Donauwörth, Bavaria, Germany (enrolling)
• Novartis Investigative Site — Herrsching am Ammersee, Bavaria, Germany (enrolling)
• Novartis Investigative Site — Kempten (Allgäu), Bavaria, Germany (enrolling)
• Novartis Investigative Site — Landsberg am Lech, Bavaria, Germany (enrolling)
• Novartis Investigative Site — Munich, Bavaria, Germany (enrolling)
• Novartis Investigative Site — Regensburg, Bavaria, Germany (enrolling)
• Novartis Investigative Site — Bremerhaven, Free Hanseatic City of Bremen, Germany (enrolling)
• Novartis Investigative Site — Kassel, Hesse, Germany (enrolling)
• Novartis Investigative Site — Offenbach, Hesse, Germany (enrolling)
• Novartis Investigative Site — Rotenburg (Wümme), Lower Saxony, Germany (enrolling)
• Novartis Investigative Site — Twistringen, Lower Saxony, Germany (enrolling)
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany (enrolling)
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany (enrolling)
• Novartis Investigative Site — Solingen, North Rhine-Westphalia, Germany (enrolling)
• Novartis Investigative Site — Wesel, North Rhine-Westphalia, Germany (enrolling)
• Novartis Investigative Site — Zittau, Saxony, Germany (enrolling)
• Novartis Investigative Site — Merseburg, Saxony-Anhalt, Germany (enrolling)
• Novartis Investigative Site — Oldenburg in Holstein, Schleswig-Holstein, Germany (enrolling)
• Novartis Investigative Site — Saalfeld, Thuringia, Germany (enrolling)
• Novartis Investigative Site — Bad Friedrichshall, Germany (enrolling)
• Novartis Investigative Site — Baden-Baden, Baden-Wurttemberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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