An Observational Study in Participants With Indolent Systemic Mastocytosis (ISM)

NCT ID: NCT07264959

Last Updated: 2025-12-04

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

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2032-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Indolent Systemic Mastocytosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants With ISM

Patients who are currently being treated or plan to be treated for ISM

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blueprint Medicines Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Blueprint Medicines

Role: CONTACT

1-888-258-7768

Blueprint Medicines, EU Contact

Role: CONTACT

+31 85 064 4001

Other Identifiers

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BLU-285-2406

Identifier Type: -

Identifier Source: org_study_id

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