Observing avapritinib treatment in people with indolent systemic mastocytosis in Germany

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional, real-world observational study following participants for up to 24 months to document how avapritinib is used and its effects in routine clinical practice. Participants are enrolled when their treating clinician starts avapritinib for ISM with moderate to severe symptoms not controlled by symptomatic therapy, and treatment follows the approved product information. Data collected will include clinical outcomes, safety events, and elements of the natural history and management of ISM. The study is conducted at several German centers, including Charité in Berlin and regional hospital sites in Bochum and Deggendorf.

Why it matters

Who can join: the full rules

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.

Where it's running

• Charité Universitätmedizin Berlin, Institut für Allergieforschung
  Berlin, Germany Recruiting
• Katholisches Klinikum Bochum
  Bochum, Germany Recruiting
• MVZ Klinikum Deggendorf
  Deggendorf, Germany Recruiting
• Universitätsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie
  Dresden, Germany Recruiting
• Universitatsmedizin Freiburg, Klinik fur Innere Medizin
  Freiburg im Breisgau, Germany Recruiting
• University Medical Center Goettingen - Georg August University of Goettingen
  Göttingen, Germany Recruiting

Study contacts

• Study coordinator: Blueprint Medicines, EU Contact
• Email: medinfoeurope@blueprintmedicines.com
• Phone: +31 85 064 4001

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-world care and outcomes for people with indolent systemic mastocytosis (ISM)

  This study will see how people with ISM are treated and how they are doing in everyday care, including those taking avapritinib.

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  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT06783790

• Long-term safety evaluation of avapritinib for mastocytosis patients

  This study is testing the long-term safety of avapritinib for patients with mastocytosis who have already benefited from the treatment in a previous study.

  Recruiting at 8 sites Phase 4 Blueprint Medicines Corporation · Edegem and 7 other locations · NCT06748001

• Combining avapritinib and decitabine for treating systemic mastocytosis with associated hematologic neoplasm

  This study is testing a new combination treatment of avapritinib and decitabine to see if it can help people with systemic mastocytosis and related blood cancers feel better and manage their condition more effectively.

  Recruiting at 2 sites Phase 1 H. Lee Moffitt Cancer Center and Research Institute · Phoenix, Arizona and 6 other locations · NCT06327685

• Using Avapritinib to treat relapsed or refractory pediatric CBF-AML with KIT mutation

  This study is testing if a new drug called avapritinib can help children with a specific type of leukemia that keeps coming back and has a certain mutation, to see if it works better than the treatments they currently have.

  Recruiting Phase 2 Children's Hospital of Soochow University · Hefei, Anhui and 11 other locations · NCT06316960

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.