Long-term safety evaluation of avapritinib for mastocytosis patients

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 study aims to assess the long-term safety of avapritinib in patients who have previously participated in a clinical study sponsored by Blueprint Medicines and have shown continued clinical benefit from the treatment. Participants will be monitored for safety outcomes as they continue receiving avapritinib. The study is designed for individuals who have completed the parent study and meet specific eligibility criteria. The focus is on patients with indolent and advanced systemic mastocytosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participated in a Blueprint Medicines sponsored avapritinib clinical study. The Sponsor reserves the right to not roll over patients who have been on drug hold for an extended time period.
* Completed End of Trial / End of Study (EOT/EOS) visit in the parent study and demonstrated compliance with the parent study requirements.
* Continue to clinically benefit from treatment with avapritinib.
* Able to give written informed consent.
* Agree to continue to use highly effective contraception as defined in this protocol.
* Female patients of childbearing potential must have negative highly sensitive serum pregnancy test within 20 days before the first dose of avapritinib. Women of nonchildbearing potential do not require this test.

Exclusion Criteria:

* Participant is participating in another interventional study.
* Participant is unwilling or unable to comply with study procedures and study restrictions.
* Participant is breastfeeding.

Other protocol-defined criteria apply.

Where it's running

• Universitair Ziekenhuis Antwerpen (UZA)
  Edegem, Belgium Recruiting
• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting
• University Hospital Aachen
  Aachen, Germany Recruiting
• A.O.U. San Giovanni di Dio e Ruggi d'Aragona di Salerno
  Salerno, Italy Recruiting
• Universitair Medisch Centrum Groningen
  Groningen, Netherlands Recruiting
• Erasmus Medisch Centrum
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Blueprint Medicines
• Email: MedInfo@blueprintmedicines.com
• Phone: 617-714-6707

Similar studies

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

• Observing avapritinib treatment in people with indolent systemic mastocytosis in Germany

  This study will see if avapritinib helps manage symptoms in people with indolent systemic mastocytosis who are starting the drug as part of routine care in Germany.

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• Combining avapritinib, azacitidine, and venetoclax for treating relapsed AML after stem cell transplant

  This study is testing a new combination of three medications to see if they can help people with relapsed acute myeloid leukemia feel better after a stem cell transplant.

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

• 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

• Evaluating Avapritinib for Advanced Gastrointestinal Stromal Tumors

  This study is testing if Avapritinib can help people with advanced gastrointestinal stromal tumors feel better and improve their health in real-world situations.

  Recruiting First Affiliated Hospital, Sun Yat-Sen University · Guangzhou · NCT05464875

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.