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).
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.
In first- or second-line treatment: presence of BCR::ABL1 fusion transcripts lacking exon a2 (e.g. e13a3, e14a3, e1a3).
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.
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.
Cohort
Prospective
Not listed
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).
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.
Percentage of Patients by Reason for TKI Treatment Decision Documented by the Treating Physician
Percentage of Patients With Dose Reduction by Reason for Dose Reduction
Percentage of Patients With Treatment Interruption by Reason for Interruption
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