About this trial
This is a non-interventional study assessing the effectiveness of avapritinib (BLU-285) in the management of ISM in real-world settings in Germany. The study also seeks to address the existing data gap in the natural history and management of participants with ISM.
The study is designed to follow each participant up to a maximum of 24 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants is starting avapritinib treatment at the HCP's discretion as part of their routine care (for ISM with moderate to severe symptoms inadequately controlled with symptomatic treatment) and in accordance with approved SmPC.
Disqualifiers
Participant with a potential increased risk for intracranial hemorrhage including those with a history of vascular aneurysm, intracranial hemorrhage, cerebrovascular accident within the prior year, or severe thrombocytopenia.
Participant who has previously taken avapritinib as a commercial drug or as part of a clinical study.
Trial population
Adult participants with ISM with moderate to severe symptoms inadequately controlled on symptomatic treatment, who are initiating treatment with commercial avapritinib according to the German approved label.
Trial design
Other
Prospective
Treatments tested in this trial
Avapritinib
DrugAvapritinib will be administered as an oral tablet.
Treatment groups
Trial outcomes
Primary outcomes
Change From Baseline in Mastocytosis Control-quality of Life (MC-QoL) Questionnaire Score at Month 6
Secondary outcomes
Socio-demographic Variable: Participant Age
Socio-demographic Variable: Participant Gender
Socio-demographic Variable: Participant Ethnicity
Socio-demographic Variable: Participant Race
Sponsors and contacts
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