A trial looking at chemotherapy and rituximab for people with newly diagnosed diffuse large B cell lymphoma who cannot have CHOP chemotherapy (R-GCVP)

Who can enter

You can enter this trial if you

• Are newly diagnosed with diffuse large B cell lymphoma (DLBCL) and it is stage 1A with a lymph node more than 10cm in size or stage 1B, 2, 3 or 4
• Have satisfactory blood test results
• Are well enough to take part in the trial (performance status 0, 1, 2 or 3)
• 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 lymphoma in your central nervous system
• Have low grade lymphoma that has changed into high grade (transformed)
• Have had low grade lymphoma in the past
• Have stage 1A lymphoma (unless you have a lymph node that is more than 10cm across)
• Have already had chemotherapy, radiotherapy or any other experimental treatment for DLBCL
• Have had any other cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix
• Have heart problems (your doctors will test how well your heart is working)
• Have any other medical condition that cannot be controlled with medicine
• Have lymphoma that is linked to HIV or AIDS infection and your immune system is badly affected (the trial doctors can advise you about this)
• Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit 60 patients at hospitals in the UK.

Everybody taking part will have chemotherapy and rituximab. You have 3 week (21 day) cycles of treatment. You will have up to 6 cycles, depending on how well the treatment is working.

On day 1 of each cycle, you have gemcitabine, cyclopshosphamide, vincristine, and rituximab through a drip into a vein. This will take a few hours. You have gemcitabine again on day 8 of each cycle. This takes about half an hour.

You take steroid tablets (prednisolone) on the first 5 days of each cycle. And on the 9th day, you have a drug called Neulasta as a small injection under your skin. This is a growth factor that helps your blood counts to recover from the chemotherapy.

The trial team will ask your permission to keep samples of tissue taken when you had a lymph node biopsy or a bone marrow test. The samples may be used in future research into the treatment of lymphoma. If you do not want to donate these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

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

• Physical examination
• Blood tests
• CT scan
• Bone marrow test
• Heart trace (ECG)
• Heart scan (MUGA or echocardiogram)

You have to stay in hospital for one night when you have your first cycle of chemotherapy. The rest of the treatment, you can have as an outpatient. You will have regular blood tests and a CT scan before the 4th cycle of treatment.

When you finish treatment, you will have a CT scan, a heart scan and blood tests. If you had lymphoma in your bone marrow at the beginning of the trial, you will also have a bone marrow test. You will have another CT scan after 3 months and another a year later. You will see the trial doctors for follow up appointments

• Every 3 months for the 1st year
• Every 4 months in the next year
• Every 6 months in the year after that

Side effects

Rituximab can cause

• Fever and chills
• Headache
• Tiredness
• Aching muscles or joints
• Itching or skin redness
• Feeling sick
• Drop in blood pressure

Before each treatment you will have paracetamol and an antihistamine drug 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.

There is more information about the side effects of rituximab, gemcitabine, cyclopshosphamide, vincristine, steroid tablets and Neulasta on CancerHelp UK.