NCT07255638

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Blueprint Medicines Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Indolent Systemic Mastocytosis

Interventions

Type	Name	Description
DRUG	Avapritinib	Avapritinib will be administered as an oral tablet.

Timeline

• Start date: 2025-12-09
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-12-01
• Last updated: 2026-04-20

Locations

8 sites across 1 country: Germany