A trial of ibrutinib for mantle cell lymphoma in people over 65 (SHINE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at ibrutinib with bendamustine and rituximab for mantle cell lymphoma. The people taking part are over 65 years of age and have only recently been diagnosed with mantle cell lymphoma.
Mantle cell lymphoma is a rare type of non Hodgkin lymphoma. Doctors usually treat it with chemotherapy and a drug called rituximab.
Researchers want to see if having a drug called ibrutinib alongside bendamustine chemotherapy and rituximab helps people with mantle cell lymphoma.
Ibrutinib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The aim of this trial is to see if having ibrutinib alongside chemotherapy and rituximab helps people over 65 who haven’t yet had any other treatment for mantle cell lymphoma.
Who can enter
You may be able to enter this trial if you
- Have recently been diagnosed with mantle cell lymphoma that is affecting 2 or more groups of lymph nodes (stage 2, 3 or 4)
- Are at least 65 years old
- Haven’t had any treatment for your lymphoma yet
- Have at least one area of lymphoma that can be measured
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You cannot enter this trial if you
- Have lymphoma in your brain or spinal cord (your central nervous system)
- Have had a stroke in the last 6 months
There are other reasons why you may or may not be able to join this trial which the trial doctors can advise you about.
Trial design
This is an international phase 3 trial. It will recruit 520 people from different countries around the world. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
Everybody will have bendamustine and rituximab. Half the people taking part will also have ibrutinib. The other half will have a dummy drug (
).
To begin with, you have 4 week cycles of treatment. You have up to 6 cycles, so your initial treatment will last nearly 6 months.
You have bendamustine through a drip into a vein on the 1st and 2nd day of each treatment cycle. You have rituximab through a drip into a vein on the 1st day only. You take ibrutinib capsules (or the dummy drug) every day. You must take them at least 30 minutes before eating or at least 2 hours after a meal.
If your lymphoma improves during this initial treatment, you can carry on having rituximab and ibrutinib (or the dummy drug if that’s what you had in the first 6 treatment cycles) for up to 2 years. This is called maintenance treatment. During this time, you have rituximab once every 8 weeks. You continue to take the capsules every day.
If your lymphoma hasn’t got any worse at the end of 2 years, you can carry on taking ibrutinib (or the dummy drug) for longer.
The trial team will give you a diary to keep at home. In this, they note how many capsules you should take. And you write in the diary when you take the capsules.
They will also ask you to fill out a questionnaire every 4 weeks during the first 6 months of treatment, every 12 weeks until you have been in the trial for 1 year, and then every 16 weeks after that. The questionnaire will ask about side effects and how you’ve been feeling.
Hospital visits
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Heart trace (
ECG ) - CT scan
You may also have
- A test called an endoscopy to look at the inside of your digestive system (if your lymphoma is affecting your stomach and intestine)
- PET scan
- Bone marrow test
The trial team will get a sample of the tissue that was removed when you had a to diagnose your lymphoma. If there is not a sample available, you will need to have a new biopsy.
During the first 6 cycles of treatment, you go to hospital on 2 days every 4 weeks. After that you go to hospital once every 8 weeks. You have a blood test at each hospital visit.
On one day in each of the first 3 treatment cycles, you have some extra blood tests before and after you take ibrutinib. These are to see how much of the drug gets into your bloodstream. On these days, the trial team will ask you not to take the capsules until you are at the hospital.
You have a CT scan every 12 weeks for the first year of treatment and then every 16 weeks after that.
The trial team may ask you to have another PET scan, bone marrow test or endoscopy.
If you have any problems with your eyes during treatment, the trial team will arrange for you to have an eye test.
When you finish treatment, you will see the trial team again about a month later. After that, they will check how you are every 16 weeks. This may be at a hospital appointment or they may contact you by phone.
Side effects
As ibrutinib is a new drug, there may be side effects we don’t know about yet. In other trials, the most common side effects have been
- Diarrhoea
- Tiredness (fatigue)
- Feeling sick
Other side effects have been
- Cough
- Swollen hands or feet
- Rash
- Colds
- High temperature (fever)
- Dizziness
- Constipation
- Aching joints or muscles
- Bruises
- Headaches
- Shortness of breath
- Being sick
- Loss of appetite
The most common side effects of bendamustine include
- Feeling or being sick
- Diarrhoea
- Heartburn
- Constipation
- Tummy (abdominal) pain or swelling
- Sore mouth
- Loss of appetite and taste changes
- Weight loss
- Headache
- Problems sleeping
- Pain in your back, arms or legs
The most common side effects of rituximab include
- A reaction when you have the drug
- Feeling or being sick
- Diarrhoea
- Weight gain
- Muscle or back pain
- Flushing
- Night sweats
- Weakness and tiredness (fatigue)
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Runny nose
The trial team will talk to you about all the possible side effects of the drugs before you agree to join the trial.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Simon Rule
Supported by
Experimental Cancer Medicine Centre (ECMC)
Janssen-Cilag
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
