A trial of Zevalin as initial treatment for follicular lymphoma (FIZZ)

Please note this trial is no longer recruiting patients.

This trial is looking at a drug called Zevalin as a first treatment for follicular lymphoma. This drug is also sometimes called 90Y ibritumomab tiuxetan.

Follicular lymphoma is the most common type of non Hodgkin’s lymphoma (NHL). If you have no symptoms or enlarged lymph nodes when you are diagnosed, your doctor may decide to keep a close eye on you. You may hear this called ‘watch and wait’. But if you are having symptoms or have enlarged lymph nodes, your doctor will want to you to start treatment.

Doctors usually treat follicular lymphoma with chemotherapy and a monoclonal antibody called rituximab.

Zevalin is a ‘radio labelled’ monoclonal antibody. This means that it has a radioactive molecule called yttrium 90 attached to it. The antibody targets a protein called CD20 on the surface of the lymphoma cells and the radioactive yttrium kills them.

Previous trials have shown that Zevalin can work well for people who have lymphoma that has come back after treatment.

The aim of this trial is to find out if having a combination of Zevalin and rituximab as an initial treatment can prevent or delay the need for treatment with chemotherapy.

Recruitment

Start 30/06/2007

End 08/04/2010

Phase

Phase 2

Who can enter

You can enter this trial if you

Have been diagnosed with follicular lymphoma and it is grade 1, 2 or 3a - your doctor will tell you if this applies to you
Have a protein called CD20 on your lymphoma cells (‘CD20 positive’ NHL) - your doctor will tell you if this applies to you
Are having symptoms or have enlarged lymph nodes and your doctor thinks that you need to begin treatment for your lymphoma
Have satisfactory blood test results
Are well enough to take part in the trial
Are willing to use reliable contraception while you are taking part in the trial (and for a year afterwards) if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have low grade lymphoma that has changed into high grade (transformed)
Have more than one type of lymphoma (discordant lymphoma)
Have water on the kidney (hydronephrosis)
Have a lymphoma tumour that measures more than 10cm across
Have had any other cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix that have been successfully treated
Have a large amount of fluid in your lungs (pleural effusion) or in your abdomen (ascites)
Have an infection that is being treated with antibiotics
Have heart disease or any other serious medical condition
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The trial will recruit 80 people. Everybody taking part will have Zevalin and rituximab.

At the beginning of the trial, you will have a bone marrow test to see if there is any lymphoma in your bone marrow. And if so, how much there is.

If the test shows that you have a lot of lymphoma in your bone marrow, you will have extra rituximab treatment for 4 weeks before you have treatment with a combination of Zevalin and rituximab.

You will have the rituximab through a drip into a vein (an intravenous infusion) once a week. This takes a few hours each time. 6 weeks later, you will have another bone marrow test and 3 weeks after that you will start the combination of Zevalin and rituximab treatment.

If your bone marrow test shows that you only have a small amount of lymphoma (or none) in your bone marrow, you will begin treatment with a combination of Zevalin and rituximab straight away.

Everybody taking part will have 2 cycles of treatment with Zevalin and rituximab. One cycle of treatment takes 2 weeks. In the first week, you will have an infusion of rituximab that will take a few hours. In the 2nd week, you will have another infusion of rituximab. Then, on the same day, you will have the Zevalin as an infusion over about half an hour. You then have 6 weeks with no treatment, followed by another 2 week cycle of Zevalin and rituximab.

Hospital visits

You will go to the hospital to see the doctors and have a number of tests before you take part in the trial. These include

You will go to the hospital at least 4 times to have your treatment. You will usually have your treatment in the outpatient department, but your doctor may want you to stay in hospital overnight.

If you have a lot of lymphoma in your bone marrow at the beginning of the trial, you will have 5 extra hospital visits to have the 4 extra rituximab infusions and another bone marrow test.

Everybody taking part will go to the hospital each week to see the doctor, and have blood tests until the results are normal. You will have a CT scan about 3 months after your last treatment. After that, you will have blood tests and a CT scan every 6 months for the next 2 years, then at least every year for the next 5 years.

Side effects

All treatments have side effects. Rituximab and Zevalin can cause

A drop in blood pressure
A rapid heart beat
Chest pain
Difficulty in breathing
Fever or chills
Feeling sick
Itchy rash
Weakness
Headache
Dizziness
Sore throat

Before each treatment, you will have paracetamol and antihistamine tablets to try to prevent or reduce these side effects. During the infusions, the nurses will monitor you very closely and any symptoms you have will be treated straight away.

Zevalin may cause a drop in your blood count around 4 to 6 weeks after you have the treatment. If this happens, you will be at an increased risk of infection or bleeding.

There is more information about the side effects of rituximab and Zevalin on CancerHelp UK.