
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is combining navitoclax with ruxolitinib for myelofibrosis.
It is open to people who:
Myelofibrosis is a . It is a rare cancer that causes scarring of the
. This makes it difficult for the bone marrow to produce blood cells.
Ruxolitinib is a for myelofibrosis. It is a
called a cancer growth blocker. It blocks a
called JAK2. By blocking JAK2 ruxolitinib slows down or stops the cancer cells growing and dividing.
Navitoclax is a targeted drug. It works by blocking proteins called BCL-2. Cancer cells need these proteins to stay alive. By blocking BCL-2 proteins navitoclax can cause the death of cancer cells.
Researchers think that combining navitoclax with ruxolitinib will help people with myelofibrosis. In this trial half the people have navitoclax and ruxolitinib. The other half have ruxolitinib and a dummy drug ().
The aims of this trial are to find out:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is an international phase 3 trial. The team need 230 people worldwide to take part with 18 people from the UK.
It is a double blinded randomised trial. There are 2 groups. Neither you nor your doctor can choose which group you are in. Nor will you or your doctor know what treatment you are having.
During the trial your doctor will be able to find out what treatment you are having if it is necessary to know.
The 2 groups are:
The dummy drug is a tablet. You take it once a day every day.
Ruxolitinib is a tablet. You take it twice a day every day.
You continue with treatment for as long as it is working and the side effects aren’t too bad.
You have a dosing diary to fill in for the first 5 weeks of treatment. The team give you instructions on how to fill it in and when.
During treatment there are certain foods, drinks and medications you should avoid having. Your doctor will talk about this with you when you join the trial.
Quality of life
You fill in a few questionnaires:
The questions asked are about:
These are quality of life questionnaires.
Research samples
You give blood samples:
You have a bone marrow test:
Researchers use these samples to find out:
You see the doctor to have tests before taking part. These tests include:
You see the doctor at regular times during treatment. This is to see how you are and to have blood tests.
A month after stopping treatment you see the doctor to see how you are. You then see the doctor every 2 months for up to 5 years or a member of the trial team will phone you.
You have a bone marrow test during treatment at:
You only then have a bone marrow test if your doctor requests. This could be because they think your cancer is getting worse.
You have an MRI scan or a CT scan regularly during treatment and then:
During the 8 years you stop having the scans if your cancer gets worse, the cancer becomes a leukaemia or you start a new treatment for your cancer.
After 24 weeks of treatment if you stop for any other reason than your cancer is getting worse you see the doctor every 12 weeks till your cancer gets worse or changes to leukaemia.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of navitoclax include:
We have information about ruxolitinib and its side effects.
Your doctor or a member of the trial team will talk to you about the side effects of the treatments before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Donald McLornan
AbbVie
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”