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

Recruiting now

Conditions studied: Indolent Systemic Mastocytosis

In brief

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.

Key facts

Study ID

NCT07255638

Run by

Blueprint Medicines Corporation

People needed

80

Starts

2025-12-09

Expected to finish

2028-12-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Charité Universitätmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie — Berlin, Germany (enrolling)
• Katholisches Klinikum Bochum — Bochum, Germany (enrolling)
• MVZ Klinikum Deggendorf — Deggendorf, Germany (enrolling)
• Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie — Dresden, Germany (enrolling)
• University Medical Center Goettingen - Georg August University of Goettingen — Göttingen, Germany (enrolling)
• Universitats-Hautklinik Tubingen, Studienzentrum lmmundermatologie — Tübingen, Germany (enrolling)
• HNO-Gemeinschaftspraxis Wiesbaden, GEKA Gesellschaft für Experimentelle und Klinische Atemwegsforschung mbH, Zentrum für Rhinologie und Allergologie — Wiesbaden, Germany (enrolling)
• Helios Universitätsklinikum Wuppertal — Wuppertal, Germany (enrolling)

Full record on ClinicalTrials.gov

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