A trial looking at treatment every 2 weeks or every 3 weeks for non Hodgkin's lymphoma (R-CHOP 14 vs R-CHOP 21)

Please note this trial is no longer recruiting patients.

This trial was comparing treatment every 2 weeks with every 3 weeks for diffuse large B cell non Hodgkin's lymphoma. But from November 2008, everybody taking part had R-CHOP every 3 weeks. You may now hear the trial called R-CHOP 21.

Diffuse large B cell non Hodgkin’s lymphoma is a type of high grade non Hodgkin’s lymphoma (NHL). For some time, the standard treatment has been a combination of chemotherapy called CHOP. This is the chemotherapy drugs cyclophosphamide, doxorubicin (Adriamycin) and vincristine, which you have once every 3 weeks. You also take prednisolone steroid tablets once a day for 5 days out of every 3 weeks.

Clinical trials have shown that having a monoclonal antibody called rituximab as well as CHOP is beneficial for some patients. This is called R-CHOP.

Other clinical trials have shown that it may be better to have CHOP every 2 weeks rather than every 3 weeks. But doctors don’t know if it is better to have R-CHOP every 2 weeks (R-CHOP 14) or every 3 weeks (R-CHOP 21).

The aim of this trial is to compare R-CHOP 14 and R-CHOP 21 to see which is better for newly diagnosed diffuse large B cell non Hodgkin’s lymphoma.

Recruitment

Start 14/03/2005

End 31/12/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Are newly diagnosed with diffuse large B cell non Hodgkin’s lymphoma (NHL)
Have a protein called CD20 on your lymphoma cells (‘CD20 positive’ NHL)
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
Are at least 18 years old

You cannot enter this trial if you

Have lymphoma in your brain or spinal cord (central nervous system)
Have NHL that is pressing on your spinal cord (spinal cord compression)
Have T cell lymphoma or transformed follicular lymphoma
Have had any treatment for your NHL already
Have had any other cancer in the last 10 years, apart from non melanoma skin cancer or carcinoma in situ of the cervix
Have heart disease or angina
Are hepatitis B, hepatitis C or HIV positive (although you won’t be tested as part of this trial)
Have any other serious medical condition

Trial design

This is a randomised trial. It will recruit 1,080 people into 2 groups.

Group 1 have R-CHOP 21. You have cyclophosphamide, doxorubicin, vincristine and rituximab through a drip into a vein once every 3 weeks. And you take prednisolone tablets once a day for 5 days every 3 weeks. Each 3 week period is one cycle. You have 6 cycles of all 5 drugs, and 2 further cycles of rituximab alone.

Group 2 have R-CHOP 14. You have cyclophosphamide, doxorubicin, vincristine and rituximab through a drip into a vein once every 2 weeks. And you take prednisolone tablets once a day for 5 days every 2 weeks. Each 2 week period is one cycle. You have 6 cycles of all 5 drugs, and 2 further cycles of rituximab alone. Please note - This group closed to recruitment in November 2008.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

Blood tests
CT scan
Heart trace (ECG)
Bone marrow biopsy
Physical examination

You may also have a heart ultrasound (echocardiogram, or ECHO) or a MUGA scan, and a sample of spinal fluid taken.

You will go to the hospital once every 2 or 3 weeks to have chemotherapy as an outpatient. If you are in group 2, you don’t need to go to hospital to have the GCSF injections. The nurses will teach you (or a family member) how to do this at home.

You will have blood tests and a physical examination before each cycle of chemotherapy. And a CT scan half way through treatment and after your last cycle of treatment. You will have another CT scan 3 months and a year after you finish treatment.

After you finish treatment, you will see the doctors every 3 months for a year, then every 6 months for another year, and every year after that.

Side effects

The most common side effects of the drugs used in this trial are

A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
Sore mouth (mucositis)
Feeling or being sick
Hair loss
Diarrhoea
Numbness or tingling in hands or feet (peripheral neuropathy)
Fever or chills after first dose of rituximab

There is more information about cyclophosphamide, doxorubicin (Adriamycin), vincristine, rituximab and prednisolone on CancerHelp UK.