What is asciminib studying for Philadelphia chromosome-positive chronic myeloid leukemia?

Asciminib is being studied to understand its real-world effectiveness, safety, and tolerability in adults with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. Researchers want to see how asciminib compares to other tyrosine kinase inhibitors used in routine care. The study is sponsored by Novartis Pharmaceuticals and aims to provide valuable information for patients and doctors.

Is there any cost to participate in this Philadelphia chromosome-positive chronic myeloid leukemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should plan accordingly for their travel needs.

Actively Recruiting

Age: 18Years - 100Years

All Genders

ID07549516

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

Q: Who may be eligible for this Philadelphia chromosome-positive chronic myeloid leukemia clinical trial?

Adults aged 18 to 100 years with a confirmed diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase may be eligible. Participants may be newly diagnosed or have been treated with exactly one prior tyrosine kinase inhibitor, depending on their treatment group. Anyone willing to attend follow-up visits and complete health questionnaires may qualify. Please review eligibility criteria for more details.

Led by Novartis Pharmaceuticals · Updated on 2026-05-15

380

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the real-world effectiveness of asciminib for adults with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase Ph CML-CP. This includes patients who are newly diagnosed or have been treated before with one tyrosine kinase inhibitor TKI. The study aims to gather information on how well asciminib works and its tolerability and safety compared to other TKIs used in routine care. The study includes three groups patients treated with asciminib, newly diagnosed patients treated with imatinib, and newly diagnosed patients treated with second-generation TKIs such as dasatinib, bosutinib, or nilotinib. Treatment decisions are made by the patients doctor as part of routine care, and treatment must start no more than 14 days before joining the study or after the baseline assessment. Patients are followed over time while receiving their assigned treatments. Participants will attend routine follow-up visits and complete questionnaires about their health and quality of life throughout the study. Researchers will measure the percentage of patients achieving a major molecular response at 12 months as the main outcome. Additional outcomes include treatment adherence, dose changes, interruptions, discontinuations, and quality of life scores. The study will continue until September 2030 to monitor safety and effectiveness in real-world settings.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients who provide written informed consent to participate in the study.
Adults 18 years of age or older with a confirmed diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase.
Patients who are newly diagnosed or have received treatment with exactly one prior tyrosine kinase inhibitor (only allowed for the Asciminib Cohort).
Patients whose doctor has decided to start treatment with asciminib or another tyrosine kinase inhibitor as part of routine care, with treatment starting no more than 14 days before study inclusion or after baseline assessment.
Patients willing to attend routine follow-up visits and complete patient-reported outcome questionnaires throughout the study.

You will not qualify if you...

Patients with contraindications to their chronic myeloid leukemia treatment as outlined in product guidelines, including specific asciminib-related concerns such as certain BCR::ABL1 fusion transcripts or mutations.
Patients receiving or planned to receive asciminib or other tyrosine kinase inhibitors in unapproved ways or doses.
Patients currently participating in an interventional clinical trial.
Patients unable or unwilling to provide written informed consent.
Patients unable to reliably complete patient-reported outcome questionnaires due to cognitive or language barriers.
Patients for whom long-term follow-up is not possible due to relocation or other logistical issues.

Research Team

Novartis Pharmaceuticals

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