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 | Recruiting

• 1 other identifier: CABL001J1DE02
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 54

Brief 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).

Conditions

Leukemia, Chronic Myeloid

Keywords

Asciminib; CML-CP; Philadelphia chromosome-positive; Real-world evidence; Non-interventional study; Germany; BCR::ABL1; Major Molecular Response; Adherence; MARS-5; EORTC QLQ-C30; EORTC QLQ-CML24; WPAI-GH; Tyrosine kinase inhibitors

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Major Molecular Response (MMR) at 12 Months

  MMR is defined as a BCR::ABL1 level ≤ 0.1% according to the International Scale (IS).

  Month 12

Secondary Outcomes (18)

• Percentage of Patients by Clinical Characteristic

  Baseline

• Percentage of Patients by Reason for TKI Treatment Decision Documented by the Treating Physician

  Baseline

• Percentage of Patients With Dose Reduction by Reason for Dose Reduction

  3, 6, 9, 12, 15, 18, 21, and 24 months

• Percentage of Patients With Treatment Interruption by Reason for Interruption

  3, 6, 9, 12, 15, 18, 21, and 24 months

• Percentage of Patients Who Discontinued Treatment by Reason for Discontinuation

  3, 6, 9, 12, 15, 18, 21, and 24 months

Study Arms (3)

Asciminib Cohort

Adult patients with Ph+ CML-CP, either newly diagnosed or previously treated with one TKI, who are treated with asciminib.

Imatinib Cohort

Adult patients newly diagnosed with Ph+ CML-CP treated with imatinib who have not received any prior TKI treatment.

Second-generation TKI Cohort

Adult patients newly diagnosed with Ph+ CML-CP treated with dasatinib, bosutinib, or nilotinib who have not received any prior TKI treatment.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Ph+ CML-CP patients, either newly diagnosed or previously treated with one ATP-competitive TKI, who initiate TKI treatment as recommended by the treating physician in a hematology center in Germany.

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 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (54)

Novartis Investigative Site

Baden-Baden, Baden-Wurttemberg, 76532, Germany

RECRUITING

Novartis Investigative Site

Heidenheim, Baden-Wurttemberg, 89522, Germany

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Novartis Investigative Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

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Novartis Investigative Site

Aschaffenburg, Bavaria, 63739, Germany

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Novartis Investigative Site

Augsburg, Bavaria, 86152, Germany

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Novartis Investigative Site

Donauwörth, Bavaria, 86609, Germany

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Novartis Investigative Site

Herrsching am Ammersee, Bavaria, 82211, Germany

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Novartis Investigative Site

Kempten (Allgäu), Bavaria, 87439, Germany

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Novartis Investigative Site

Landsberg am Lech, Bavaria, 86899, Germany

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Novartis Investigative Site

Munich, Bavaria, 81241, Germany

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Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

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Novartis Investigative Site

Bremerhaven, Free Hanseatic City of Bremen, 27576, Germany

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Novartis Investigative Site

Kassel, Hesse, 34125, Germany

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Novartis Investigative Site

Offenbach, Hesse, 63065, Germany

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Novartis Investigative Site

Rotenburg (Wümme), Lower Saxony, 27356, Germany

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Novartis Investigative Site

Twistringen, Lower Saxony, 27239, Germany

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Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50674, Germany

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Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50677, Germany

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Novartis Investigative Site

Solingen, North Rhine-Westphalia, 42653, Germany

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Novartis Investigative Site

Wesel, North Rhine-Westphalia, 46483, Germany

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Novartis Investigative Site

Zittau, Saxony, 02763, Germany

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Novartis Investigative Site

Merseburg, Saxony-Anhalt, 06217, Germany

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Novartis Investigative Site

Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

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Novartis Investigative Site

Saalfeld, Thuringia, 07318, Germany

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Novartis Investigative Site

Bad Friedrichshall, 74177, Germany

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Novartis Investigative Site

Bad Liebenwerda, 04924, Germany

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Novartis Investigative Site

Berlin, 12487, Germany

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Novartis Investigative Site

Bremerhaven, 27568, Germany

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Novartis Investigative Site

Buchholz Nordheide, 21244, Germany

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Novartis Investigative Site

Cottbus, 03046, Germany

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Novartis Investigative Site

Detmold, 32756, Germany

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Novartis Investigative Site

Dorfen, 84405, Germany

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Novartis Investigative Site

Dortmund, 44263, Germany

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Novartis Investigative Site

Dresden, 01307, Germany

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Novartis Investigative Site

Düren, 52353, Germany

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Novartis Investigative Site

Erfurt, 99085, Germany

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Novartis Investigative Site

Göttingen, 37073, Germany

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Novartis Investigative Site

Hanover, 30161, Germany

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Novartis Investigative Site

Hanover, 30625, Germany

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Novartis Investigative Site

Hildesheim, 31135, Germany

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Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Leverkusen, 51375, Germany

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Novartis Investigative Site

Mutlangen, 73557, Germany

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Novartis Investigative Site

Naunhof, 04683, Germany

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Novartis Investigative Site

Neuss, 41462, Germany

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Novartis Investigative Site

Offenburg, 77654, Germany

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Novartis Investigative Site

Oldenburg, 26121, Germany

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Novartis Investigative Site

Parchim, 19370, Germany

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Novartis Investigative Site

Potsdam, 14467, Germany

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Novartis Investigative Site

Potsdam, 14482, Germany

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Novartis Investigative Site

Schorndorf, 73614, Germany

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Novartis Investigative Site

Soest, 59494, Germany

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Novartis Investigative Site

Stade, 21680, Germany

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Novartis Investigative Site

Wetzlar, 35578, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 24, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (54)