A study of treatment for a type of Hodgkin lymphoma in children and young people (EuroNet PHL-LP1)

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

Cancer type:

Children's cancers

Hodgkin lymphoma

Lymphoma

Status:

Closed

Phase:

Other

This is a study looking at treatment for a type of Hodgkin lymphoma called nodular lymphocyte predominant type. The study is supported by Cancer Research UK.

More about this trial

This study is for children and young people under the age of 18. We use the term 'you' in this summary, but of course if you are a parent, we are referring to your child.

Treatment for early stage Hodgkin lymphoma is often very successful. If you have nodular lymphocyte predominant type, you may have surgery to remove lymph nodes, followed by chemotherapy. But the chemotherapy drugs can cause some long term side effects.

Doctors think that children and young people who have nodular lymphocyte predominant Hodgkin lymphoma may be able to have less chemotherapy than people with classical types of Hodgkin lymphoma. And some may be able to have surgery alone and not need to have any chemotherapy at all.

In this study, the researchers want to find out whether you need to have any further treatment if you’ve had all your lymphoma removed.

If your lymphoma can’t be completely removed, they also want to find out whether you can safely have less chemotherapy than the standard treatment Open a glossary item for Hodgkin lymphoma.

Who can enter

You may be able to enter this study if you

Have nodular lymphocyte predominant Hodgkin lymphoma that is stage 1A or 2A
Are under 18 years of age

You cannot enter this study if you

Have lymphoma outside your lymph nodes or lymphoma that is more advanced than stage 1A or 2A
Have already had other treatment for Hodgkin lymphoma
Have taken steroids in the last 30 days
Have had an experimental drug as part of another clinical trial in the last 30 days
Are known to be very sensitive to any of the drugs in the study
Have another type of cancer or any other serious medical condition
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is an international study that will recruit about 200 children and young people in a number of European countries.

The treatment you have will depend on the stage of your lymphoma and whether or not it can all be removed with surgery.

If there are no signs of lymphoma after you’ve had surgery to remove your lymph nodes Open a glossary item , you won’t have any further treatment. You will have regular follow up appointments with the study team.

If there is still some lymphoma left, and this can’t be removed with another small operation (or you don’t want to have more surgery), you will have chemotherapy. You have a low dose of chemotherapy called CVP. This is a combination of the drugs cyclophosphamide, vinblastine and prednisolone in 2 week cycles of treatment.

You have 3 cycles of chemotherapy. You have cyclophosphamide through a drip into a vein once every 2 weeks. You have vinblastine through a drip once a week. You take prednisolone tablets for 8 days in every 2 weeks.

In this study, if you have chemotherapy, treatment will last between 6 and 9 weeks in total.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood tests
CT scan
PET scan
Ultrasound scan of your liver and spleen

You may also have an MRI scan. A group of experts in Europe will look at the results of these scans to work out the stage of your Hodgkin lymphoma and decide whether or not you need to have chemotherapy.

If you do have chemotherapy, you go to hospital once every week for up to 9 weeks. After you finish chemotherapy, you have a CT or MRI scan.

Everybody taking part will have follow up appointments with the study team for the next 5 years. How often you see the team and the number of tests or scans you have will depend on your individual situation and where you have your treatment. Your doctors will tell you more about this.

Side effects

In this study, the dose of CVP chemotherapy is much lower than that used to treat classical types of Hodgkin lymphoma. If you do have any side effects, they are likely to be milder and last for a shorter time than side effects of standard dose CVP. The side effects of standard dose CVP include