Study Description
The purpose of this study is to enhance the knowledge on asciminib treatment in a broader
and real-life population by collecting additional data to characterize the treatment
patterns of patients treated with asciminib, with a primary objective represented by
maintenance on treatment at 12 months. The ASSURE-3 study is a national, multicentric, non-interventional, prospective study in
real-life conditions with primary data collection in adult patients with Philadelphia
chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously
treated with two or more Tyrosine Kinase Inhibitors (TKIs). It will be conducted in
France with hematologists, onco-hematologists, physicians with documented involvement in
managing Ph+ CML-CP patients in routine practice, practicing in public or private health
care institutions. Each patient will be followed during 15 months at M0, M1 and then
every 3 months (rhythm of visits according to the routine clinical care), or until
premature discontinuation of asciminib treatment.
Historical data will be abstracted retrospectively by the participating physicians from
patient files, to collect information using an electronic case report form (eCRF).
Primary data will be collected during inclusion and follow-up visits
Interventions
Asciminib
Eligibility Criteria
Inclusion Criteria:
1. Patient aged ≥ 18 years at inclusion,
2. Patient with Ph+ CML-CP previously treated with two or more TKIs,
3. Patient for whom a decision has been taken by the treating physician (investigator)
to initiate treatment with asciminib according to his own practice, the drug label /
Summary of Product Characteristics (SmPC), and regardless of study participation,
4. Patient having given their non objection to participate to the study
Exclusion Criteria:
1. Patient with CML in accelerated phase (AP) or blastic phase (BP) at enrolment,
2. Patient with known history of T315I mutation,
3. Patient who previously received asciminib treatment,
4. Patient currently participating to an interventional clinical trial,
5. Patient with known contra-indication to asciminib according to the SmPC.
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