A trial looking at Zevalin and chemotherapy for relapsed follicular lymphoma (SCHRIFT)

Please note this trial is no longer recruiting patients.

This trial is looking at Zevalin with a short course of chemotherapy for follicular lymphoma that has come back after earlier treatment.

Follicular lymphoma is the most common type of non Hodgkin's lymphoma (NHL). Doctors usually treat follicular lymphoma with 6 to 8 cycles of CHOP chemotherapy and a monoclonal antibody called rituximab. This is known as RCHOP. We know from research that this works better than chemotherapy alone.

Sometimes, doctors use radiotherapy too, but this combination of treatments can cause a lot of side effects. Reducing the treatment to 3 cycles of chemotherapy and adding a drug called Zevalin (instead of radiotherapy) may cause fewer side effects.

Zevalin is a 'radio labelled' monoclonal antibody. This means that it has a radioactive molecule called yttrium 90 attached to it (pronounced it-ree-um). The antibody finds lymphoma cells by seeking out a protein called CD20 on the cells’ surface. The radioactive yttrium then kills them.

Other trials have shown that Zevalin can work well for people who have lymphoma that has come back after treatment. The aims of this trial are to see how well Zevalin works with a shorter course of chemotherapy and whether there are fewer side effects.

Recruitment

Start 21/04/2008

End 20/08/2010

Phase

Other

Who can enter

You can enter this trial if you

Have follicular lymphoma that is grade 1, 2 or 3A - your doctor will tell you if this applies to you
Have lymphoma that has come back (relapsed) at least 6 months after having chemotherapy and rituximab - if you had chemotherapy on its own, you can take part if your lymphoma has come back within 6 months
Have a protein called CD20 on your lymphoma cells - your doctor will tell you if this applies to you
Have lymphoma that is stage 2, 3 or 4
Have lymphoma symptoms that your doctor thinks will be helped if you start treatment
Are well enough to take part in the trial (performance status 0, 1 or 2)
Have satisfactory blood test results
Are willing to use reliable contraception during 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 had a drug within another clinical trial in the last 4 weeks
Have not recovered from the side effects of other treatment
Have lymphoma that has spread to your brain or spinal cord (central nervous system)
Had a lymphoma tumour that measured more than 10cm across when you were first diagnosed
Have had treatment with a radiolabelled monoclonal antibody in the past
Have water on the kidneys (hydronephrosis)
Have heart problems (your doctor will test how well your heart is working)
Have another serious medical condition that could affect you taking part in this trial
Have had any other type of cancer, unless it has been in complete remission for at least 5 years, or it was non melanoma skin cancer or carcinoma in situ of the cervix that was successfully treated
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This trial will recruit 60 people in the UK. Everybody taking part will have rituximab and either CHOP or CVP chemotherapy. CVP is a combination of the drugs cyclophosphamide, vincristine and prednisolone steroid tablets. You have chemotherapy in 3 week cycles of treatment.

You have chemotherapy and rituximab through a drip into a vein (an infusion) on the first day of each cycle. And you take the steroid tablets for 5 days of each cycle. You have 3 cycles of treatment.

Two weeks after the last cycle of chemotherapy, you have a CT scan. A week later, you have rituximab on its own. And a week after that, on the same day, you have rituximab and Zevalin through a drip.

If you have lymphoma in more than a quarter of your bone marrow at the start of the trial, you will have a bone marrow test after 3 cycles of chemotherapy. If this shows that the treatment has helped, you will have Zevalin. If you still have lymphoma in more than a quarter of your bone marrow, you will not be able to carry on in the trial. Your doctor will discuss other treatment options with you.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
CT scan
Chest X-ray
Heart trace (ECG)
Heart scan (MUGA) or echocardiogram
Bone marrow test

You may also have a lymph node biopsy if it is more than a year since you had one.

Most people can have chemotherapy, rituximab and Zevalin as an outpatient, but you may have to stay in hospital overnight.

After the treatment finishes, you will have regular blood tests. These will be every week for the first 3 months. After that, you will continue to see the doctors and have blood tests every 3 months for 2 years and then every 6 months for up to 5 years.

You will have a CT scan about 3 months after the treatment and again after 12 months, 18 months and 30 months. If you had lymphoma in your bone marrow, you will have a bone marrow test 18 weeks after treatment and again 2 years later.

Side effects

The most common side effects of rituximab and Zevalin include

A drop in blood pressure
A rapid heart beat
Chest pain
Wheezing or breathing problems
Fever or chills
Feeling or being sick
Itching or rash
Weakness
Headache or dizziness
Coughing or sore throat

Before each treatment, you will have paracetamol and antihistamine tablets to try to reduce or prevent 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 the number of blood cells around 4 to 6 weeks after you have the treatment. If this happens, you will be at an increased risk of infection or bleeding until your blood counts recover.

There is more information about side effects of rituximab, Zevalin, cyclophosphamide, doxorubicin, vincristine and steroids on CancerHelp UK.