This CML disease registry (ASC4REAL-2) aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes (PRO) in real-world healthcare from patients with Ph+-CML-CP treated with TKIs approved for 1L and 2L, including prospective follow-up for 5 years identifying and describing long-term treatment outcomes.
18 years or older at the time of Ph+-CML-CP diagnosis.
Receiving TKI treatment (asciminib, bosutinib, dasatinib, imatinib, or nilotinib) in routine medical care either as initial therapy or after 1 prior TKI therapy.
Receiving treatment at US and US territories (i.e., Puerto Rico) medical practice (e.g. community-based, office-based, hospital-based, academic).
Signed informed consent form (ICF) prior to participation in the study including agreement to be tokenized so that the patient's anonymized RWD (EMRs and/or claims data) can be accessed.
Active participation in an interventional trial that may influence the management of their Ph+-CML-CP disease.
Currently being treated with a CML TKI in 3L or beyond.
Known presence of T315I mutation.
Currently in TFR phase and are not on active CML TKI therapy.
Patients with Ph+-CML-CP who, at enrollment, are receiving 1 of 5 TKI treatments included in this registry either as initial therapy or after 1 prior TKI therapy.
Cohort
Prospective
TKIs
Other interventionThere is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.
Rate of discontinuation of index TKI due to AEs
Rate of discontinuation of index Tyrosine kinase inhibitor (TKI) due to Adverse Events (AEs)
Overview of AEs
Overview of Adverse Events (AEs) to be provided
Rate and time to switches in TKI
Rate and time to switches in TKI to be provided
Time to discontinuation of TKI, and reasons for TKI treatment discontinuatio
Time to discontinuation of TKI, and reasons for TKI treatment discontinuation to be provided
Distributions of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
PRO-CTCAE provides assessment on individual symptom/side effect related to gastrointestinal signs/symptoms (diarrhea, constipation, nausea, vomiting), cardiovascular, sleep/wake, fatigue, headache, rash, muscle spasms, myalgia, joint pain, shortness of breath/coughing/chest pain, and edema. PRO-CTC AE scores range from 0 to 4 (4 stands for very severe)
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