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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.
Show all 11Show fewer
  • 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

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

69 sites in 1 country

Germany69 sites, 69 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

    Recruiting

Other trials in Germany

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).

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 groups in NCT07549516
Study groupRoleWhat they receive
Asciminib CohortAdult patients with Ph+ CML-CP, either newly diagnosed or previously treated with one TKI, who are treated with asciminib.
Imatinib CohortAdult patients newly diagnosed with Ph+ CML-CP treated with imatinib who have not received any prior TKI treatment.
Second-generation TKI CohortAdult 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.

  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).

    Measured: Month 12

Secondary outcomes (19)

  1. 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

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

    Measured: Baseline

  3. Percentage of Patients With Dose Reduction by Reason for Dose Reduction

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

  4. Percentage of Patients With Treatment Interruption by Reason for Interruption

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

  5. Percentage of Patients Who Discontinued Treatment by Reason for Discontinuation

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

  6. Time to Treatment Discontinuation

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

  7. Time to Treatment Interruption

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

  8. Time to Dose Reduction

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

  9. Time to Treatment Discontinuation due to Adverse Events (TTDAE)

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

  10. Percentage of Patients With Early Molecular Response (EMR) at 3 Months

    EMR is defined as BCR::ABL1 ≤10% IS.

    Measured: Month 3

  11. 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

  12. Percentage of Patients With MMR

    MMR is defined as BCR::ABL1 ≤0.1% IS.

    Measured: 3, 6, 9, 15, 18, 21, and 24 months

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  1. First posted24 Apr 2026
  2. Study start17 Apr 2026
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, Chronic Myeloid, run by Novartis Pharmaceuticals at 69 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Major Molecular Response (MMR) at 12 Months (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07549516.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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