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

Blueprint Medicines Corporation80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Indolent Systemic Mastocytosis

Interventions

AvapritinibDRUG

Avapritinib will be administered as an oral tablet.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Charité Universitätmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie

Berlin, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie

Dresden, Germany

RECRUITING

University Medical Center Goettingen - Georg August University of Goettingen

Göttingen, Germany

Outcomes

Primary Outcomes

Change From Baseline in Mastocytosis Control-quality of Life (MC-QoL) Questionnaire Score at Month 6

Time frame: Baseline, Month 6