A trial to improve treatment for children and young people with Hodgkin lymphoma (EuroNet PHL C2)

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

Cancer type:

Blood cancers
Children's cancers
Hodgkin lymphoma
Lymphoma

Status:

Closed

Phase:

Phase 3

This trial is comparing different ways of treating Hodgkin lymphoma to help lower the risk of long term side effects.

The trial is for children and young people up to the age of 25. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.

More about this trial

The usual treatment for Hodgkin lymphoma is chemotherapy and radiotherapy. This treatment works well. But radiotherapy can cause long term side effects later in life such as heart problems.  

We know from research that many people don’t need radiotherapy if chemotherapy worked well. So researchers want to see if it is possible to reduce the need for radiotherapy. But they want to do this without affecting the number of children and young people who are successfully treated. 

Researchers plan to do this by giving some people more intensive chemotherapy. The drugs you have in this trial are standard treatments Open a glossary item. But some people have a newer and stronger combination.

The trial team look at how widespread your lymphoma is. And if you have any other factors, such as big lumps of lymphoma, that might make it more difficult to treat. Depending on this you are put into 1 of the following 3 groups. These are 

  • early stage 
  • intermediate stage
  • advanced stage

Your treatment plan depends on the group you are in. 

The main aims of the trial are to find out if:

  • it is possible to reduce the use of radiotherapy 
  • intensive (stronger) chemotherapy means you won’t need radiotherapy
  • it is possible to treat more children and young people successfully with the new treatment plans 

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. 
You:

  • have Hodgkin lymphoma
  • are under the age of 25
  • are willing to use reliable contraception during treatment and for one year after you stop treatment if you are sexually active

Who can’t take part

You cannot join this trial if any of these apply. 
You:

  • have had treatment for Hodgkin lymphoma already, unless you had 7 to 10 days of steroid treatment for a large tumour in your chest
  • have a type of lymphoma call lymphocyte predominant Hodgkin lymphoma
  • have had chemotherapy or radiotherapy in the past for another cancer
  • have any other cancer
  • are allergic to any of the drugs in the trial
  • have HIV
  • have had treatment with an experimental drug or device in the last 30 days
  • have any other medical problem or mental health condition that the trial team think would affect you taking part
  • are pregnant or breastfeeding
     

Trial design

This is a phase 3 trial. The researchers need 2,200 children and young people to take part including 318 from the UK. 

You are put into 1 of the following groups based on how far your lymphoma has spread. These are:

  • early stage 
  • intermediate stage
  • advanced stage

Initial chemotherapy
Everyone has 2 cycles Open a glossary itemof OEPA chemotherapy. This includes the drugs:

You then have a PET scan Open a glossary item to see how well treatment worked. Depending on the results you have 1 of the following: 

  • more chemotherapy if there aren’t any cancer cells present 
  • more chemotherapy followed by radiotherapy if there are cancer cells present

Although you don’t have more chemotherapy if you have early stage lymphoma. You have radiotherapy only.

Your doctor will talk to you about the treatment you have. 

More chemotherapy 
In the low risk group, you have 1 cycle of a combination of chemotherapy called COPDAC-28 if a PET scan shows treatment has worked. This means the lymphoma has stayed the same and there are fewer cancer cells.

In the intermediate or advanced group, you are put into a treatment group by computer. This part of the trial is randomised. Neither you nor your doctor can choose which group you are in. 

You have 1 of the following combinations of chemotherapy:

  • COPDAC-28 (cyclophosphamide, vincristine, prednisolone and dacarbazine) 
  • DECOPDAC-21 (doxorubicin, etoposide, cyclophosphamide, vincristine, prednisolone and dacarbazine

COPDAC-28 is a standard treatment. DECOPDAC-21 is a new and more intensive treatment.

You have:

  • 2 cycles of treatment in the intermediate group
  • 4 cycles of treatment in the advanced group

You have chemotherapy as a drip into a vein or into a central line Open a glossary item such as a PICC line or a portacath. One of the drugs you have is called prednisolone. This is a tablet you take by mouth. 

How often you have treatment depends on which group you are in. The trial team can tell you more about this.

Radiotherapy
You have radiotherapy after you finish chemotherapy. But only if the first chemotherapy didn’t work. You have a PET scan to work out exactly how much radiotherapy to have, and which areas to treat. 

You have standard radiotherapy in the low risk group instead of COPDAC-28 chemotherapy if OEPA didn’t work.

In the intermediate or advanced group, you have standard radiotherapy if you had COPDAC 28. You then have a second PET scan later to work out if you need to have a boost of radiotherapy added to standard radiotherapy.   

In the intermediate or advanced group, you don’t have radiotherapy if you had DECOPDAC 21 and it worked. If DECOPDAC 21 didn’t work you have a second PET scan a bit later to monitor the lymphoma. If there are areas of active lymphoma then you have a boost of radiotherapy to these areas.  

The trial team can tell you more about how often you have radiotherapy. And how long it takes each time. 

Hospital visits

You see a doctor and have some tests before you can take part in this trial. These include:

You have more PET scans during treatment to check how well it is working. You see a doctor for regular check ups during treatment. 

When you finish treatment, you may have a check up at:

  • 6 weeks
  • 3 months
  • 6 months
  • 9 months
  • 1 year

You have an MRI scan at:

  • 3 months 
  • 12 months 

And the team repeat some of the other tests you had done when you joined the trial. 

The trial team follow you up every:

  • 4 months in the 2nd and 3rd year
  • 6 months in the 4th and 5th year

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad, or not getting better. 
 
The most common side effects of chemotherapy include:

The short term side effects of radiotherapy include:

The long term side effects of radiotherapy are:

  • thyroid problems such as an underactive thyroid gland Open a glossary item 
  • heart problems such as abnormal heart rhythms, congestive heart failure or damage to the sac that surrounds the heart
  • secondary cancers Open a glossary item

We have more information about:

    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

    Dr Stephen Daw

    Supported by

    Blood Cancer UK
    University of Birmingham
     

    Freephone 0808 800 4040

    Last review date

    CRUK internal database number:

    16082

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

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