A trial looking at CHOP-R and Zevalin for patients over 60 years old with diffuse large B cell non Hodgkin's lymphoma

Please note this trial is no longer recruiting patients.

This trial is looking at a short course of chemotherapy with a new drug called Zevalin for people over 60 years of age with diffuse large B cell non Hodgkin's lymphoma.

Diffuse large B cell non Hodgkin’s lymphoma is a type of high grade (aggressive) non Hodgkin’s lymphoma (NHL). The standard treatment for all B cell lymphomas is a combination of drugs called CHOP-R. This includes the chemotherapy drugs cyclophosphamide, doxorubicin (Adriamycin), vincristine, the steroid prednisolone and a monoclonal antibody called rituximab (Mabthera). Some patients over 60 years old are not well enough to have 6 cycles of full dose CHOP-R treatment. Doctors think that having less CHOP-R and adding a new drug called Y ibritumomab tiuxetan (Zevalin) may be better for this group of patients.

Zevalin is a “radio labelled” monoclonal antibody. This means it has a radioactive molecule called yttrium 90 attached to it. The antibody targets the CD20 protein on the surface of NHL B cells, and the radioactive yttrium kills them. Previous trials on a small number of patients with aggressive lymphoma have shown that a single dose of Zevalin can work well and improve quality of life.

The aims of the trial are to find out

The best dose of Zevalin to use
What the side effects are
How well it works for diffuse large B cell NHL

Recruitment

Start 01/10/2005

End 03/09/2010

Phase

Phase 2

Who can enter

You can enter this trial if you

Have recently been diagnosed with diffuse large B cell non Hodgkin’s lymphoma (NHL)
Have a protein called CD20 on your lymphoma cells (“CD20 positive” NHL) - your doctor will be able to tell you if this applies to you
Are well enough for treatment (performance status 0, 1 or 2)
Have satisfactory blood test results
Are willing to use reliable contraception while you are taking part in this trial if there is any chance you or your partner could become pregnant
Have lymphoma in less than a quarter of your bone marrow
Are 60 years or over

You cannot enter this trial if you

Have lymphoma in your brain or spinal cord (central nervous system)
Are HIV positive (although you won’t be tested as part of this trial)
Have poor liver or kidney function
Have any other serious medical condition
Have had treatment as part of another clinical trial or had surgery in the last 4 weeks
Are still recovering from side effects from treatments you have had
Have had any other cancer, apart from non melanoma skin cancer or carcinoma in situ of the cervix which was successfully treated
Have fluid in your lungs (pleural effusion) or fluid in your abdomen (ascites) and that is the only sign that you have cancer
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit about 40 patients into 2 groups. Which group you are in will depend on how many patients have already been recruited. All patients taking part will have CHOP-R, rituximab and Zevalin.

If you are in group 1, you will have 5 cycles of CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisolone and rituximab) through a drip into a vein. One cycle is 3 weeks of treatment. After the last cycle of CHOP-R you will have rituximab followed by Zevalin on the same day.

If you are in group 2, you will have 4 cycles of CHOP-R through a drip into a vein. One cycle is 3 weeks of treatment. After the second and fourth cycle of CHOP-R, you will have one dose of rituximab followed by Zevalin on the same day.

Hospital visits

Before you start your treatment you will see a doctor and have some tests. These tests include

Physical examination
Blood tests
Urine tests
CT scan
Blood pressure, heart rate and temperature
Chest X-ray
Bone marrow test
Heart trace (ECG)

You will have some of these tests again during and after your treatment. Your doctor will tell you more about this nearer the time.

If you are in group 1 you will go to the outpatient department for 5 cycles of CHOP-R over 15 weeks. You will go to the hospital again at the end of the last cycle to have rituximab and Zevalin.

If you are in group 2, you will go to the outpatient department for 4 cycles of CHOP-R over nearly 4 months (15 weeks). You will also have rituximab and Zevalin at the end of the second cycle and the fourth cycle of CHOP-R.

You will have CHOP-R, rituximab and Zevalin as an outpatient. But you may need to stay in hospital overnight from time to time. Your doctor will discuss this with you in more detail.

You will need to go to the hospital after your treatment has finished for follow up appointments. You will have blood tests every week to begin with. After that, you will see the doctor every 3 months for up to 2 years, then every 6 months until 5 years. You may also have a bone marrow test. This will depend on the results of the bone marrow test you had before treatment.

Side effects

All chemotherapy drugs have side effects. The most common side effects of CHOP are

A drop in blood cells causing increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
Hair loss
Feeling or being sick

The most common side effects of rituximab and Zevalin are