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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-09

Study Completion Date

2028-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Indolent Systemic Mastocytosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Avapritinib

Participants will receive avapritinib as part of their treatment plan with their healthcare practitioner (HCP) and in accordance with the Summary of Product Characteristics (SmPC).

Avapritinib

Intervention Type DRUG

Avapritinib will be administered as an oral tablet.

Interventions

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Avapritinib

Avapritinib will be administered as an oral tablet.

Intervention Type DRUG

Other Intervention Names

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Ayvakyt BLU-285

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No