Menu
Recruiting NCT06748001

Avapritinib Rollover Study

Phase IV Interventional Mastocytosis, Systemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Avapritinib.
Who it may be relevant to
Registry conditions: Mastocytosis, Systemic. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Canada, Italy, Netherlands, Norway +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Multicenter, Rollover Study in Patients Who Participated in an Avapritinib Clinical Study

Overview

The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.

Interventions

  • Drug Avapritinib
    Avapritinib will be administered in accordance with the parent study protocol.

Primary outcome measures

  • Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation [Time frame: Up to approximately 4 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 2 centers
  • Universitair Medisch Centrum Groningen — Groningen
  • Erasmus Medisch Centrum — Rotterdam
Belgium · 1 center
  • Universitair Ziekenhuis Antwerpen (UZA) — Edegem
Canada · 1 center
  • The Hospital for Sick Children — Toronto
Italy · 1 center
  • A.O.U. San Giovanni di Dio e Ruggi d'Aragona di Salerno — Salerno
Norway · 1 center
  • Oslo University Hospital — Oslo
United Kingdom · 1 center
  • Guys and St Thomas NHS Foundation Trust - St Thomas Hospital — London

Identifiers

NCT: NCT06748001 · BLU-285-2404

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗