Menu
Recruiting NCT07549516

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

— Observational Leukemia, Chronic Myeloid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Leukemia, Chronic Myeloid. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Primary outcome measures

  • Percentage of Patients With Major Molecular Response (MMR) at 12 Months [Time frame: Month 12]
Secondary outcome measures (12)
  • Percentage of Patients by Clinical Characteristic [Time frame: Baseline]
  • Percentage of Patients by Reason for TKI Treatment Decision Documented by the Treating Physician [Time frame: Baseline]
  • Percentage of Patients With Dose Reduction by Reason for Dose Reduction [Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months]
  • Percentage of Patients With Treatment Interruption by Reason for Interruption [Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months]
  • Percentage of Patients Who Discontinued Treatment by Reason for Discontinuation [Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months]
  • Time to Treatment Discontinuation [Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months]
  • Time to Treatment Interruption [Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months]
  • Time to Dose Reduction [Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months]
  • Time to Treatment Discontinuation due to Adverse Events (TTDAE) [Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months]
  • Percentage of Patients With Early Molecular Response (EMR) at 3 Months [Time frame: Month 3]
  • Percentage of Patients With Molecular Response 2 (MR2) [Time frame: 3, 6, 9, 12, 15, 18, 21, and 24 months]
  • Percentage of Patients With MMR [Time frame: 3, 6, 9, 15, 18, 21, and 24 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 54 centers
  • Novartis Investigative Site — Baden-Baden
  • Novartis Investigative Site — Heidenheim
  • Novartis Investigative Site — Schwäbisch Hall
  • Novartis Investigative Site — Aschaffenburg
  • Novartis Investigative Site — Augsburg
  • Novartis Investigative Site — Donauwörth
  • Novartis Investigative Site — Herrsching am Ammersee
  • Novartis Investigative Site — Kempten (Allgäu)
  • … and 46 more centers

Identifiers

NCT: NCT07549516 · CABL001J1DE02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗