A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany
A Prospective Non-Interventional Study to Describe the Effectiveness of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Patients With Indolent Systemic Mastocytosis and Symptoms That Are Not Adequately Controlled With Symptomatic Treatments in Real-World Settings
Blueprint Medicines Corporation
80 participants
Dec 9, 2025
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria1
- 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.
Exclusion Criteria2
- 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.
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Interventions
Avapritinib will be administered as an oral tablet.
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT07255638