🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT07549516
Recruiting Observational

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

NCT07549516 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2026-04-17
Last updated
2026-09-03

Condition(s) studied

Leukemia, Chronic Myeloid

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion criteria: 1. Written informed consent must be obtained before participation in the study/prior to any study-related documentation. 2. Adult patients (≥18 years of age) with a confirmed diagnosis of Ph+ CML-CP. The presence of the Philadelphia chromosome may alternatively be confirmed by molecular detection of a BCR::ABL1 fusion gene/transcript (e.g., by reverse transcription polymerase chain reaction (RT-PCR)), in accordance with the World Health Organization (WHO) 2022 classification. 3. 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. 4. 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. 5. Patients willing to participate in routine follow-up visits and complete patient-reported outcome questionnaires over the course of the study. Exclusion criteria: 1. 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), as well as additional disease- or treatment-related characteristics associated with distinct clinical scenarios that differ from the intended study population, including situations with specific treatment requirements or limited comparability, in which reliable interpretation of study outcomes may not be feasible, 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, e1a3). * In second-line treatment: * known BCR::ABL1 mutations associated with partial or complete resistance to asciminib (e.g. M244V, F359I/V/C). * presence of the BCR::ABL1 T315I mutation, regardless of eligibility for treatment according to SmPC (e.g., specific indication and dosing regimens). 2. 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. 3. Patients currently participating in an interventional clinical trial. 4. Patients unable or unwilling to provide written informed consent. 5. Patients who are unable to reliably complete patient-reported outcome questionnaires due to cognitive or language limitations relevant to the study assessments. 6. Patients for whom long-term follow-up is not feasible due to expected relocation or other logistical constraints. 7. The restriction to a maximum of one prior ATP-competitive TKI applies exclusively to patients treated with asciminib. Patients in the comparator cohorts (imatinib, dasatinib, bosutinib, nilotinib) must be TKI-naïve and are included at the start of their first-line TKI therapy and are not eligible if they have received any prior TKI treatment.

Primary outcome measure(s)

Trial sites (65)

FacilityCityRegionStatus
Novartis Investigative Site Baden-Baden Baden-Wurttemberg Recruiting
Novartis Investigative Site Heidenheim Baden-Wurttemberg Recruiting
Novartis Investigative Site Schwäbisch Hall Baden-Wurttemberg Recruiting
Novartis Investigative Site Winnenden Baden-Wurttemberg Recruiting
Novartis Investigative Site Aschaffenburg Bavaria Recruiting
Novartis Investigative Site Augsburg Bavaria Recruiting
Novartis Investigative Site Donauwörth Bavaria Recruiting
Novartis Investigative Site Herrsching am Ammersee Bavaria Recruiting
Novartis Investigative Site Kempten (Allgäu) Bavaria Recruiting
Novartis Investigative Site Landsberg am Lech Bavaria Recruiting
Novartis Investigative Site Munich Bavaria Recruiting
Novartis Investigative Site Regensburg Bavaria Recruiting
Novartis Investigative Site Bremerhaven Free Hanseatic City of Bremen Recruiting
Novartis Investigative Site Kassel Hesse Recruiting
Novartis Investigative Site Offenbach Hesse Recruiting
Novartis Investigative Site Goslar Lower Saxony Recruiting
Novartis Investigative Site Rotenburg (Wümme) Lower Saxony Recruiting
Novartis Investigative Site Twistringen Lower Saxony Recruiting
Novartis Investigative Site Cologne North Rhine-Westphalia Recruiting
Novartis Investigative Site Cologne North Rhine-Westphalia Recruiting
Novartis Investigative Site Solingen North Rhine-Westphalia Recruiting
Novartis Investigative Site Wesel North Rhine-Westphalia Recruiting
Novartis Investigative Site Zittau Saxony Recruiting
Novartis Investigative Site Merseburg Saxony-Anhalt Recruiting
Novartis Investigative Site Oldenburg in Holstein Schleswig-Holstein Recruiting
Novartis Investigative Site Berlin State of Berlin Recruiting
Novartis Investigative Site Saalfeld Thuringia Recruiting
Novartis Investigative Site Bad Friedrichshall Germany Recruiting
Novartis Investigative Site Bad Liebenwerda Germany Recruiting
Novartis Investigative Site Berlin Germany Recruiting
Novartis Investigative Site Berlin Germany Recruiting
Novartis Investigative Site Berlin Germany Recruiting
Novartis Investigative Site Berlin Germany Recruiting
Novartis Investigative Site Bremerhaven Germany Recruiting
Novartis Investigative Site Buchholz Nordheide Germany Recruiting
Novartis Investigative Site Cottbus Germany Recruiting
Novartis Investigative Site Detmold Germany Recruiting
Novartis Investigative Site Dorfen Germany Recruiting
Novartis Investigative Site Dortmund Germany Recruiting
Novartis Investigative Site Dresden Germany Recruiting

+ 25 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07549516 on ClinicalTrials.gov ↗ ← All trials in Germany