NCT07549516招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 65
- 主要终点
- Percentage of Patients With Major Molecular Response (MMR) at 12 Months
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
Imatinib Cohort
Adult patients newly diagnosed with Ph+ CML-CP treated with imatinib who have not received any prior TKI treatment.
Asciminib Cohort
Adult patients with Ph+ CML-CP, either newly diagnosed or previously treated with one TKI, who are treated with asciminib.
结局指标
主要结局
Percentage of Patients With Major Molecular Response (MMR) at 12 Months
时间窗: Month 12
MMR is defined as a BCR::ABL1 level ≤ 0.1% according to the International Scale (IS).
次要结局
- Percentage of Patients by Clinical Characteristic(Baseline)
- Percentage of Patients by Reason for TKI Treatment Decision Documented by the Treating Physician(Baseline)
- Percentage of Patients With Dose Reduction by Reason for Dose Reduction(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Percentage of Patients With Treatment Interruption by Reason for Interruption(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Percentage of Patients Who Discontinued Treatment by Reason for Discontinuation(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Time to Treatment Discontinuation(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Time to Treatment Interruption(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Time to Dose Reduction(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Time to Treatment Discontinuation due to Adverse Events (TTDAE)(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Percentage of Patients With Early Molecular Response (EMR) at 3 Months(Month 3)
- Percentage of Patients With Molecular Response 2 (MR2)(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Percentage of Patients With MMR(3, 6, 9, 15, 18, 21, and 24 months)
- Medication Adherence Report Scale (MARS-5) Score(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(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(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Work Productivity and Activity Impairment - General Health (WPAI-GH) Score(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Percentage of Patients With Deep Molecular Response: MR4.0(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Percentage of Patients With Deep Molecular Response: MR4.5(3, 6, 9, 12, 15, 18, 21, and 24 months)
- Percentage of Patients With Deep Molecular Response: MR5(3, 6, 9, 12, 15, 18, 21, and 24 months)
研究者
研究点 (65)
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