A trial looking at chemotherapy and rituximab for mantle cell lymphoma (Mantle Cell P3)

Who can enter

You can enter this trial if you

• Have been diagnosed with mantle cell lymphoma
• Have not had treatment for your lymphoma yet and your doctors think you need treatment
• Are well enough to have treatment
• Are prepared to use reliable contraception while you are taking part in the trial if there is any chance that you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have had chemotherapy in the past
• Are known to be allergic to this type of monoclonal antibody
• Have poor kidney or liver function
• Are known to be HIV positive, have hepatitis B or hepatitis C (you will not need to be tested as part of this trial)
• Have had any other cancer in the last 5 years, apart from in situ cancer of the cervix that was removed with an operation, or non melanoma skin cancer
• Have any other serious medical condition that is not under control with medication
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit about 400 patients into 2 groups. People taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1 you will have fludarabine and cyclophosphamide tablets daily for 3 days. You will then have no treatment for the next 3 and a half weeks. This 4 week period makes up a treatment cycle. If you cannot take tablets, you will have the chemotherapy as a drip into the vein.

If you are in group 2 you will have fludarabine and cyclophosphamide tablets daily for 3 days. You will then have no treatment for the next 3 and a half weeks. This 4 week period makes up a treatment cycle. If you cannot take tablets, you will have the chemotherapy as a drip into the vein. You will also have rituximab through a drip into a vein on the first day of each cycle.

Everyone taking part in this trial will have up to 4 cycles of treatment, and then have some tests. If the tests show the treatment is working, you will have up to 4 more cycles of treatment. But if the tests show that your lymphoma has continued to grow, your doctor will probably decide to stop treatment. They will discuss other treatment options with you.

The researchers would like to look at a sample of your lymphoma that was kept by the doctors when you had your biopsy. They will use this to find out more about any genetic changes in lymphoma cells.

Hospital visits

You will go to the hospital for some tests before you can take part in the trial. These include

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

You may also need to have an endoscopy.

Everyone will go to hospital on the first day of each treatment cycle. You will see the doctors and have a physical examination and a blood test at each visit.

If you are taking the chemotherapy as tablets you will only need to come to the hospital on the first day of each cycle, and you can take your chemotherapy tablets at home. If you are in group 2 you will have rituximab on the first day of each cycle.

If you cannot take tablets, and you have chemotherapy as a drip into a vein, you will need to come to the hospital for treatment, on the first 3 days of each cycle.

You will have a CT scan after 4 cycles and 8 cycles of treatment, and you may also need to have further bone marrow tests.

After you finish treatment you will carry on seeing the doctors. Exactly how often you see the doctors will depend on the usual practice at your hospital. Your doctor will tell you more about this.

Side effects

The most common side effects of fludarabine and cyclophosphamide are

• A drop in blood cells causing an increased risk of infection, shortness of breath, tiredness and bleeding or bruising problems
• Feeling or being sick
• Loss of appetite
• Hair loss or hair thinning
• Loss of fertility

Rituximab doesn’t tend to cause serious side effects. But when you first have rituximab you may have side effects such as

• Chills and fever
• Feeling sick
• Itchy rash
• Headache

There’s more information about fludarabine, cyclophosphomide and rituximab on CancerHelp UK.