An Observational Study in Participants With Indolent Systemic Mastocytosis (ISM)
Recruiting now
Conditions studied: Indolent Systemic Mastocytosis
In brief
This is a Phase 4, non-interventional, observational study to collect detailed data on the clinical characteristics, clinical outcomes and medical management of ISM in real-world settings. The study will describe the demographic and clinical characteristics of ISM participants, including anaphylaxis and bone manifestations in ISM. Quality of life and disease control will be assessed through participant questionnaires. The study will also evaluate real world ISM treatment management, including use of avapritinib.
Key facts
- Study ID
- NCT07264959
- Run by
- Blueprint Medicines Corporation
- People needed
- 150
- Starts
- 2026-04-15
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female adult participants (≥ 18 years of age) with a diagnosis of ISM according to the World Health Organization (WHO) diagnostic criteria
- Participant is currently being treated or plans to be treated with symptom-directed therapies and/or avapritinib for ISM.
You may not qualify if…
- Participants with advanced systemic mastocytosis (AdvSM) or another associated hematologic neoplasm
- Participants with smoldering systemic mastocytosis
- Ongoing participation in interventional studies in systemic mastocytosis (SM) at the time of enrollment
- Participants currently receiving treatment with a KIT inhibitor other than avapritinib at the time of enrollment.
Where it is running
- Institute for Allergy and Asthma — Wheaton, Maryland, United States (enrolling)
- Brigham and Women's Allergy and Clinical Immunology, Mass General Brigham Healthcare Center (Chestnut Hill) — Chestnut Hill, Massachusetts, United States (enrolling)
- University of Michigan Allergy Clinic — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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