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A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany

RECRUITINGSponsored by Blueprint Medicines Corporation
Actively Recruiting
SponsorBlueprint Medicines Corporation
Started2025-12-09
Est. completion2028-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07255638

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions2

CancerIndolent Systemic Mastocytosis

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