Clinical trial · Observational
A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany
A Prospective Non-Interventional Study to Describe the Effectiveness of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Patients With Indolent Systemic Mastocytosis and Symptoms That Are Not Adequately Controlled With Symptomatic Treatments in Real-World Settings
- 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 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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avapritinib | Drug | Avapritinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Avapritinib
- description
- 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).
- interventionNames
- Drug: Avapritinib
Primary outcomes (1)
- measure
- Change From Baseline in Mastocytosis Control-quality of Life (MC-QoL) Questionnaire Score at Month 6
- timeFrame
- Baseline, Month 6
Secondary outcomes (19)
- measure
- Socio-demographic Variable: Participant Age
- timeFrame
- Baseline (Day -30 to Day -1)
- measure
- Socio-demographic Variable: Participant Gender
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available