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New drug avapritinib under Real-World watch for mastocytosis relief

NCT ID NCT07255638

Disease control Sponsor: Blueprint Medicines Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 80 people in Germany with indolent systemic mastocytosis whose symptoms are not well controlled by current treatments. Researchers will track how avapritinib affects quality of life and symptom control over up to 24 months in everyday medical practice. The goal is to see how well the drug works outside of a controlled trial setting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult participants with ISM with moderate to severe symptoms inadequately controlled on symptomatic treatment, who are initiating treatment with commercial avapritinib according to the German approved label.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

indolent systemic mastocytosis mastocytosis Mastocytosis, Systemic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Indolent systemic mastocytosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Charité Universitätmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie

    RECRUITING

    Berlin, 10117, Germany

  • HNO-Gemeinschaftspraxis Wiesbaden, GEKA Gesellschaft für Experimentelle und Klinische Atemwegsforschung mbH, Zentrum für Rhinologie und Allergologie

    RECRUITING

    Wiesbaden, 65205, Germany

  • Helios Universitätsklinikum Wuppertal

    RECRUITING

    Wuppertal, 42283, Germany

  • Katholisches Klinikum Bochum

    RECRUITING

    Bochum, 44791, Germany

  • MVZ Klinikum Deggendorf

    RECRUITING

    Deggendorf, 94469, Germany

  • Universitats-Hautklinik Tubingen, Studienzentrum lmmundermatologie

    RECRUITING

    Tübingen, 72076, Germany

  • University Medical Center Goettingen - Georg August University of Goettingen

    RECRUITING

    Göttingen, 37075, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie

    RECRUITING

    Dresden, 01307, Germany

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