Leukemia, Chronic MyeloidASC2ADHERENCT07549516
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
An observational study of Leukemia, Chronic Myeloid, run by Novartis Pharmaceuticals at 69 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Leukemia, Chronic Myeloid
- How many people
- 380 participants
- Where
- 69 sitesGermany
- Study dates
- 17 Apr 2026to 30 Sep 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Written informed consent must be obtained before participation in the study/prior to any study-related documentation.
- 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.
- 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.
Who cannot join
- 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).
- 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.
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- 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.
- 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.
Trial locations and contacts
69 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
69 sites in 1 country
Germany69 sites, 69 recruiting
- Recruiting
Novartis Investigative Site
Altenburg, Thuringia, 04600
- Recruiting
Novartis Investigative Site
Aschaffenburg, Bavaria, 63739
- Recruiting
Novartis Investigative Site
Augsburg, Bavaria, 86152
- Recruiting
Novartis Investigative Site
Bad Friedrichshall, 74177
- Recruiting
Novartis Investigative Site
Bad Liebenwerda, 04924
- Recruiting
Novartis Investigative Site
Bad Saarow, 15526
- Recruiting
Novartis Investigative Site
Baden-Baden, Baden-Wurttemberg, 76532
- Recruiting
Novartis Investigative Site
Berlin, 10365
- Recruiting
Novartis Investigative Site
Berlin, 10437
- Recruiting
Novartis Investigative Site
Berlin, 10559
- Recruiting
Novartis Investigative Site
Berlin, 12487
- Recruiting
Novartis Investigative Site
Berlin, 12552
- Recruiting
Novartis Investigative Site
Bremerhaven, Free Hanseatic City of Bremen, 27576
- Recruiting
Novartis Investigative Site
Bremerhaven, 27568
- Recruiting
Novartis Investigative Site
Buchholz Nordheide, 21244
- Recruiting
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50674
- Recruiting
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50677
- Recruiting
Novartis Investigative Site
Cottbus, 03046
- Recruiting
Novartis Investigative Site
Deggendorf, 94469
- Recruiting
Novartis Investigative Site
Detmold, 32756
- Recruiting
Novartis Investigative Site
Donauwörth, Bavaria, 86609
- Recruiting
Novartis Investigative Site
Dorfen, 84405
- Recruiting
Novartis Investigative Site
Dortmund, 44263
- Recruiting
Novartis Investigative Site
Dresden, 01127
- Recruiting
Novartis Investigative Site
Dresden, 01307
- Recruiting
Novartis Investigative Site
Düren, 52353
- Recruiting
Novartis Investigative Site
Erfurt, 99084
- Recruiting
Novartis Investigative Site
Erfurt, 99085
- Recruiting
Novartis Investigative Site
Eschweiler, 52249
- Recruiting
Novartis Investigative Site
Goslar, Lower Saxony, 38642
- Recruiting
Novartis Investigative Site
Göttingen, 37073
- Recruiting
Novartis Investigative Site
Hanover, 30161
- Recruiting
Novartis Investigative Site
Hanover, 30625
- Recruiting
Novartis Investigative Site
Heidenheim, Baden-Wurttemberg, 89522
- Recruiting
Novartis Investigative Site
Herrsching am Ammersee, Bavaria, 82211
- Recruiting
Novartis Investigative Site
Hildesheim, 31135
- Recruiting
Novartis Investigative Site
Kassel, Hesse, 34125
- Recruiting
Novartis Investigative Site
Kempten (Allgäu), Bavaria, 87439
- Recruiting
Novartis Investigative Site
Kiel, 24105
- Recruiting
Novartis Investigative Site
Landsberg am Lech, Bavaria, 86899
- Recruiting
Novartis Investigative Site
Leipzig, 04103
- Recruiting
Novartis Investigative Site
Leverkusen, 51375
- Recruiting
Novartis Investigative Site
Merseburg, Saxony-Anhalt, 06217
- Recruiting
Novartis Investigative Site
Munich, Bavaria, 81241
- Recruiting
Novartis Investigative Site
Mutlangen, 73557
- Recruiting
Novartis Investigative Site
Naunhof, 04683
- Recruiting
Novartis Investigative Site
Neuss, 41462
- Recruiting
Novartis Investigative Site
Offenbach, Hesse, 63065
- Recruiting
Novartis Investigative Site
Offenburg, 77654
- Recruiting
Novartis Investigative Site
Oldenburg, 26121
- Recruiting
Novartis Investigative Site
Oldenburg in Holstein, Schleswig-Holstein, 23758
- Recruiting
Novartis Investigative Site
Parchim, 19370
- Recruiting
Novartis Investigative Site
Potsdam, 14467
- Recruiting
Novartis Investigative Site
Potsdam, 14482
- Recruiting
Novartis Investigative Site
Regensburg, Bavaria, 93053
- Recruiting
Novartis Investigative Site
Rotenburg (Wümme), Lower Saxony, 27356
- Recruiting
Novartis Investigative Site
Saalfeld, Thuringia, 07318
- Recruiting
Novartis Investigative Site
Schorndorf, 73614
- Recruiting
Novartis Investigative Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
- Recruiting
Novartis Investigative Site
Schwetzingen, 68723
- Recruiting
Novartis Investigative Site
Soest, 59494
- Recruiting
Novartis Investigative Site
Solingen, North Rhine-Westphalia, 42653
- Recruiting
Novartis Investigative Site
Stade, 21680
- Recruiting
Novartis Investigative Site
Torgau, 04860
- Recruiting
Novartis Investigative Site
Twistringen, Lower Saxony, 27239
- Recruiting
Novartis Investigative Site
Wesel, North Rhine-Westphalia, 46483
- Recruiting
Novartis Investigative Site
Wetzlar, 35578
- Recruiting
Novartis Investigative Site
Winnenden, Baden-Wurttemberg, 71364
- Recruiting
Novartis Investigative Site
Zittau, Saxony, 02763
About this study
Official 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
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
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 12
Secondary outcomes (19)
Percentage of Patients by Clinical Characteristic
Characteristics include, but are not limited to, detection of Philadelphia chromosome or BCR::ABL1 transcript, prior treatment, and Eastern Cooperative Oncology Group (ECOG) performance status.
Measured: Baseline
Percentage of Patients by Reason for TKI Treatment Decision Documented by the Treating Physician
Measured: Baseline
Percentage of Patients With Dose Reduction by Reason for Dose Reduction
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Percentage of Patients With Treatment Interruption by Reason for Interruption
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Percentage of Patients Who Discontinued Treatment by Reason for Discontinuation
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Time to Treatment Discontinuation
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Time to Treatment Interruption
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Time to Dose Reduction
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Time to Treatment Discontinuation due to Adverse Events (TTDAE)
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Percentage of Patients With Early Molecular Response (EMR) at 3 Months
EMR is defined as BCR::ABL1 ≤10% IS.
Measured: Month 3
Percentage of Patients With Molecular Response 2 (MR2)
MR2 is defined as BCR::ABL1 ≤1% IS.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Percentage of Patients With MMR
MMR is defined as BCR::ABL1 ≤0.1% IS.
Measured: 3, 6, 9, 15, 18, 21, and 24 months
Percentage of Patients With Deep Molecular Response: MR4.0
Deep Molecular Response (MR4.0): ≤0.01% BCR::ABL1 IS and Reference gene copies >10,000 ABL1 or >24,000 GUSB.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Percentage of Patients With Deep Molecular Response: MR4.5
Deep Molecular Response (MR4.5): ≤0.0032% BCR::ABL1 IS and Reference gene copies >32,000 ABL1 or >77,000 GUSB.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Percentage of Patients With Deep Molecular Response: MR5
Deep Molecular Response (MR5): ≤0.001% BCR::ABL1 IS and Reference gene copies >100,000 ABL1 or >240,000 GUSB.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Medication Adherence Report Scale (MARS-5) Score
The MARS-5 questionnaire is a validated self-report questionnaire developed to assess patient adherence to prescribed medication, focusing on both intentional and unintentional non-adherence. It consists of 5 items, each rated on a 5-point Likert Scale from 0 (always) to 5 (never). The total score ranges from 5 to 25, with higher scores indicating better adherence to treatment.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
The EORTC QLQ-C30 contains 30 questions answered by the patient. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role functioning, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health status/Quality of Life (QOL) scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but 2 questions have 4-point scales ranging from "Not at all" to "Very much." The 2 questions concerning global health status/QOL have 7-point scales with ratings ranging from "Very poor" to "Excellent." For each of the 14 domains, final scores are transformed such that they range from 0-100, where higher scores indicate improvement.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for CML (EORTC QLQ-CML24) Score
The EORTC QLQ-CML24 was designed to supplement the QLQ-C30 - the QLQ-CML24 is not a stand-alone instrument but is to be used in conjunction with the QLQ-C30.
The EORTC QLQ-CML24 is composed of 4 multi-item scales and 2 single-item scales. The module consists of 24 items assessing symptom burden (13 items), impact on worry/mood (4 items), impact on daily life (3 items), satisfaction with care and information (2 items) body image problems (1 item) and satisfaction with social life (1 item). The items are measured on 4 levels: 1=not at all, 2=a little, 3=quite a bit, 4=very much. For each domain, scores are averaged and transformed to 0 to 100.
A higher score in symptom burden, impact on worry/mood, impact on daily life, and body image problems domains indicates a worse outcome. A higher score in satisfaction with social life and satisfaction with care and information domains indicates a higher level of satisfaction.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Work Productivity and Activity Impairment - General Health (WPAI-GH) Score
The WPAI-GH is a patient-reported 6 item questionnaire which addresses absenteeism, presenteeism, overall work productivity loss, and activity impairment for the 7 days prior to the assessment. Work productivity and activity impairment outcomes are presented as impairment percentages ranging from 0 to 100 with a higher percentage indicating greater impairment and less productivity.
Measured: 3, 6, 9, 12, 15, 18, 21, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start17 Apr 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Chronic MyeloidStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549516
- Sponsor's protocol ID
- CABL001J1DE02
- Acronym
- ASC2ADHERE
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Individual data sharing
- No