NCT07264959 An Observational Study in Participants With Indolent Systemic Mastocytosis (ISM)
| NCT ID | NCT07264959 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Blueprint Medicines Corporation |
| Condition | Indolent Systemic Mastocytosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2032-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-04-15 with a primary completion date of 2032-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07264959 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Indolent Systemic Mastocytosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07264959 currently recruiting?
Yes, NCT07264959 is actively recruiting participants. Contact the research team at medinfo@blueprintmedicines.com for enrollment information.
Where is the NCT07264959 trial being conducted?
This trial is being conducted at Aurora, United States, Normal, United States, Wheaton, United States, Chestnut Hill, United States and 3 additional locations.
Who is sponsoring the NCT07264959 clinical trial?
NCT07264959 is sponsored by Blueprint Medicines Corporation. The trial plans to enroll 150 participants.