Clinical trial · Observational
An Observational Study in Participants With Indolent Systemic Mastocytosis (ISM)
An Observational Study in Patients With Indolent Systemic Mastocytosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent Systemic Mastocytosis | Indolent Systemic Mastocytosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Participants With ISM
- description
- Patients who are currently being treated or plan to be treated for ISM
Primary outcomes (5)
- measure
- Baseline Demographics
- timeFrame
- Baseline (Month 1)
- measure
- Change From Baseline in Patient-Reported Outcomes Scores
- timeFrame
- Baseline up to Month 61
- measure
- Change From Baseline in Serum KIT D816V Variant Allele Frequency (VAF)
- timeFrame
- Baseline up to Month 61
- measure
- Change From Baseline in Serum Tryptase
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available