RecruitingPHASE4INTERVENTIONAL

Avapritinib Rollover Study

This study, called the Avapritinib Rollover Study, is for people who have a rare blood condition called mastocytosis. It aims to see how safe the medicine avapritinib is over a long period. To join, you must already be taking avapritinib in another Blueprint Medicines study and feel better because of it. Think of it as a continuation study – if the medicine is helping you in your current study, this allows you to keep taking it safely while being carefully monitored. The study will check your health regularly to make sure the medicine continues to be safe and helpful for you.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Blueprint Medicines Corporation

Enrolment target

Start

28 Nov 2024

Estimated completion

31 Dec 2027

Mastocytosis, Systemic

What is this study about?

This study is called the Avapritinib Rollover Study. It’s for people who have a condition called mastocytosis. Mastocytosis is a rare disease where certain immune cells, called mast cells, build up in different parts of the body, which can cause many different symptoms like skin rashes, stomach problems, and bone pain.

The main aim of this study is to look at the long-term safety of a medicine called avapritinib. This medicine is already being used in other studies for mastocytosis. If you’re currently taking avapritinib in one of those studies and it’s really helping you feel better, this 'rollover' study lets you keep taking it.

Doctors want to keep a close eye on people who benefit from avapritinib to make sure it continues to be safe and that any possible side effects are understood over a longer time. This helps them learn more about how well and how safely the medicine works in the real world for people who need it.

Key takeaways

This study is for long-term follow-up of avapritinib for mastocytosis.
You must already be using and benefiting from avapritinib in another Blueprint Medicines study.
The main goal is to check the medicine's safety over time.
You'll have regular health check-ups and monitoring.
You can continue a treatment that is already working for you.

Who may be eligible?

To be able to join this study, you must have already been taking avapritinib in another study run by Blueprint Medicines. It's important that this medicine is currently helping you with your mastocytosis symptoms.

You also need to be able to understand the study information and give your written permission to take part. Women who could become pregnant will need to use effective birth control during the study and have a negative pregnancy test before starting. Men will also need to agree to use effective contraception.

You cannot join if you are taking part in another study that involves new medicines, if you are breastfeeding, or if you can't follow the study's instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been taking avapritinib in another Blueprint Medicines study?
Is avapritinib currently helping my mastocytosis symptoms?
Am I able to understand and sign consent forms?
Am I willing to use effective birth control if applicable?
Am I free from other interventional studies and not breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive avapritinib. The exact schedule of visits and tests will be explained by your study team, but generally, you'll have regular check-ups with doctors and nurses who will monitor your health and how the medicine is affecting you. This will likely involve physical exams, blood tests, and discussions about your symptoms and any side effects. The total duration of your participation will depend on how long you continue to benefit from the treatment and how long the study continues, but it's designed for long-term follow-up.

Potential risks and benefits

A potential benefit of joining this study is that you can continue to receive a treatment that is already helping you manage your mastocytosis. This could mean continued relief from your symptoms and an improved quality of life. Like all medicines and studies, there are potential risks, which will be fully explained by the study team. These might include side effects from the medication or the discomfort of study procedures like blood tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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

Common questions

What is mastocytosis?

Mastocytosis is a rare condition where certain immune cells, called mast cells, build up in your body, leading to various symptoms.

What is avapritinib?

Avapritinib is a medicine being studied for the treatment of mastocytosis.

Why is it called a 'rollover' study?

It's called a rollover study because it allows patients who are already benefiting from avapritinib in a previous study to continue receiving the medicine and be monitored long-term.

Will I have to pay to be in the study?

No, you will not have to pay for the study medication or study-related procedures.

Can I stop taking part if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Blueprint Medicines

medinfo@blueprintmedicines.com 617-714-6707 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.