A trial looking at rituximab and chemotherapy as a treatment for follicular lymphoma in elderly patients (PACIFICO)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 3

This trial is looking at a combination of rituximab and chemotherapy as a treatment for follicular lymphoma in patients 60 years of age and older. This trial is supported by Cancer Research UK.

More about this trial

Follicular lymphoma is the most common type of non Hodgkin lymphoma (NHL). If you have no symptoms or enlarged nodes when you are diagnosed, your doctor may decide to keep a close eye on you. You may hear this called ‘watch and wait’. But if you are having symptoms or have enlarged nodes, your doctor will want to start treatment.

Doctors usually treat follicular lymphoma with chemotherapy and a monoclonal antibody called rituximab. But doctors are not sure which combination of rituximab and chemotherapy is best for older patients.

This trial is comparing the combinations

  • Rituximab, cyclophosphamide, vincristine and prednisolone
  • Rituximab, fludarabine and cyclophosphamide

The aim of this trial is to find out which is the better combination for people 60 years of age and older.

Who can enter

You can enter this trial if you

  • Have been diagnosed with follicular lymphoma and it is grade 1, 2 or 3a
  • Have lymphoma symptoms that your doctor thinks will be helped if you start treatment
  • Have lymphoma that is stage 2, 3 or 4
  • Have satisfactory blood results
  • Are well enough to take part in this trial (performance status 0, 1, 2)
  • Are willing to use reliable contraception if there is a any chance you or your partner could become pregnant
  • Are 60 years of age or over (younger patients can take part if they are not able to have anthracycline Open a glossary item drugs)

You cannot enter this trial if you

  • Have grade 3b follicular lymphoma
  • Have follicular lymphoma that has changed to large B cell lymphoma
  • Have had lymphoma in your brain or spinal cord (central nervous system)
  • Have had treatment for lymphoma before (if you had 1 course of radiotherapy for your lymphoma you can still take part)
  • Have had surgery, except for lymph node biopsy, in the past 28 days
  • Have had treatment as a part of another trial in the past 30 days
  • Are sensitive to the drugs in this trial
  • Have been taking more than a certain dose of steroids in the last 4 weeks - your doctor can advise you about this (please note, you must never stop taking steroids before talking to your doctor)
  • Have moderate to severe nerve damage (neuropathy)
  • Currently have any other cancer apart from non melanoma skin cancer or carcinoma in situ of the cervix
  • Have had any other cancer in the past unless there has been no sign of it for at least 3 years after surgery to cure it
  • Are known to be HIV positive
  • Are known to be hepatitis B or hepatitis C positive
  • Have another serious medical condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This trial will recruit about 428 patients in the UK. It is a randomised trial. Neither you nor your doctor can choose which group you are in. There are 2 treatment groups, which are

You often have cancer treatment in cycles. In this trial people having RCVP will have treatment every 3 weeks. People having RFC will have treatment every 4 weeks. To start with, you will have 4 lots of treatment. Then you will have tests to see how well it has worked. If your cancer has stayed the same, or got bigger, you will have no more treatment as a part of this trial. Your doctor will discuss other treatment options with you. But if your cancer has shrunk, you will have 4 more lots of treatment.

The treatment for group 1 is rituximab, cyclophosphamide and vincristine through a drip into a vein once every 3 weeks. After your 1st cycle you may have rituximab as an injection under the skin. You also have prednisolone tablets daily for 5 days, starting on the day of your chemotherapy. If you have 4 more treatment cycles, you have the same again.

The treatment for group 2 is rituximab through a drip into a vein once every 4 weeks. You also have fludarabine and cyclophosphamide tablets daily for 3 days, starting on the day of your rituximab drip. After your 1st cycle you may have rituximab as an injection under the skin. If you have 4 more treatment cycles, you have rituximab only.

After 8 cycles of treatment, you will have tests to see how well it has worked. If your cancer has not grown, you will have rituximab every 2 months for a total of 2 years. This is called ‘maintenance treatment’. If your cancer has grown, you will not have any more treatment as a part of this trial. Your doctor will discuss other treatment options with you.

You will be asked to fill in some questionnaires before you start treatment, after 3 months, 6 months and then every 4 months. These will ask how you are feeling and what activities you can do. They are called quality of life questionnaires.

If you take part in this trial, the researchers will ask your permission to take extra blood samples, and samples of tissue from when you had a biopsy. These samples will be stored safely and may be used in the future for research. Studying these samples may help researchers learn more about follicular lymphoma.

If you don’t wish to give these extra 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 a number of tests before taking part in this trial. These tests include

During treatment, every 3 weeks you will have blood tests.

At 3 and 6 months, you will see the doctor and have the following tests

  • CT scan
  • Bone marrow test
  • Blood tests
  • Physical examination

During ‘maintenance treatment’ you see the doctor every 2 months and have a physical examination and blood tests. Once maintenance treatment has finished, you see the doctor 2 months later for

  • CT scan
  • Bone marrow test
  • Blood tests
  • Physical examination

Then every 4 months you will see the doctor and have a physical examination and blood tests.

Side effects

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

Rituximab can also cause flu like symptoms, sweats and a drop in blood pressure.

We have more information about side effects of rituximab, cyclophosphamide, vincristine, fludarabine and prednisolone in our cancer drugs section.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof Andrew Pettitt

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/08/024.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

2412

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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