A trial of ibrutinib with chemotherapy and rituximab for a type of diffuse large B cell lymphoma (PHOENIX)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 3

This trial is looking at a drug called ibrutinib for a type of non Hodgkin lymphoma called diffuse large B cell lymphoma (DLBCL). It is for people who have a particular type of DLBCL and who haven’t had any other treatment for their lymphoma.

More about this trial

Diffuse large B cell lymphoma (DLBCL) is a type of non Hodgkin lymphoma. It is the most common type of high grade non Hodgkin lymphoma.

There are different types of DLBCL. The people taking part in this trial have a type called non GCB. Just over half of people diagnosed with DLBCL have this type.

Doctors usually treat DLBCL with a chemotherapy drug combination called CHOP and a monoclonal antibody called rituximab. This treatment is called R-CHOP.

The non GCB type of DLBCL tends to be faster growing than some other types and it may not respond as well to treatment. So researchers are looking for other ways to treat it. In this trial, they are looking at a drug called ibrutinib.

Ibrutinib is a type of biological therapy. Is it 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 R-CHOP helps people who have recently been diagnosed with the non GCB type of diffuse large C cell lymphoma and haven’t had any other treatment yet.

Who can enter

You may be able to enter this trial if

You have recently been diagnosed with diffuse large B cell lymphoma and you have the non GCB type. The trial team will test a sample of your lymphoma to check this
Your lymphoma is affecting 2 or more groups of lymph nodes (stage 2, 3 or 4)
You have at least one area of lymphoma that can be measured and is at least 1cm across
You haven’t had any treatment for your lymphoma yet
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You have satisfactory blood test results
You are at least 18 years old
You are willing to use reliable contraception during the trial and for up to a year afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have lymphoma that has spread to your brain or spinal cord (your central nervous system)
Have lymphoma that started in the centre of your chest (mediastinal lymphoma)
Have had a low grade lymphoma in the past
Have had major surgery in the last 4 weeks
Have had any other cancer in the last 3 years apart from non melanoma skin cancer or lentigo maligna melanoma that was successfully treated
Have already had a high dose of a type of chemotherapy drug called an anthracycline – your doctor can advise you about this
Need to take a drug such as warfarin to thin your blood
Need to take certain other drugs that can affect body substances called cytochrome P enzymes (the trial team can advise you about this)
Have had a stroke or bleeding into your brain in the last 6 months
Have had a heart attack in the last 6 months or have certain other heart problems – the trial team can advise you about this
Are known to be HIV positive
Have hepatitis B or C infection
Have any other medical condition that the trial team think would affect your taking part
Are pregnant or breastfeeding

Trial design

This phase 3 trial will recruit about 800 people in different countries.

It is a randomised trial. The people taking part are put into 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 has the drugs rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone. This is called R-CHOP. Half the people taking part also have ibrutinib. The other half have a dummy drug (a placebo Open a glossary item ).

PHOENIX trial diagram

You have 3 week cycles of treatment. On the first day of each treatment cycle you have rituximab, cyclophosphamide, doxorubicin and vincristine through a drip into vein. You take prednisolone tablets on the first 5 days of each treatment cycle.

You take ibrutinib (or the dummy drug) as capsules. You take 4 capsules once every day.

You may have 6 or 8 cycles of treatment. If you stop having R-CHOP because you have bad side effects, but your lymphoma hasn’t got worse, you can carry on taking ibrutinib (or the dummy drug). As long as you don’t have bad side effects, and your lymphoma doesn’t get worse, you can continue taking it until you would have finished your chemotherapy.

The trial team will ask you to fill out a questionnaire before you start treatment, at the beginning of each treatment cycle, when you finish treatment and at follow up appointments for up to 5 years. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

They will also give you a diary card to write down when you take the capsules each day.

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 )
Heart scan (echocardiogram or MUGA scan )
CT scan
PET scan
MRI scan
Bone marrow test

The trial team will get a sample of your lymphoma that was removed when you had a lymph node biopsy in the past. If there is not a sample available, they may ask you to have another lymph node biopsy.

You go to hospital for treatment every 3 weeks. You have weekly blood tests.

You have a CT scan after 4 cycles of treatment. The trial team may ask you to have another lymph node biopsy if your lymphoma starts to get worse.

When you finish treatment, you have a CT scan and a PET scan about 3 weeks later. You may have another bone marrow test. You see the trial team about a month after you finish treatment.

After that, you have a CT scan and see the trial team

Every 4 months for 2 years
Every 6 months for the next 3 years

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

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 R-CHOP include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Hair loss
Feeling or being sick
Sore mouth
Loss of appetite and taste changes
Diarrhoea
Fatigue

The trial team will give you more information about all the possible side effects of the different drugs before you agree to take part in the trial.