Purpose of trial
The aim of this trial is to reduce unnecessary treatment for children and young people with classical Hodgkin lymphoma and reduce side effects, including late effects.
Treatment for classical Hodgkin lymphoma in children and young people is usually successful. Most children and young people are treated with chemotherapy. If there is still lymphoma after two cycles of chemotherapy, the chemotherapy is usually followed by radiotherapy. However, radiotherapy can cause health problems later in life (late effects). There is already research showing that many people do not need radiotherapy if they have a good response to chemotherapy. This trial aims to find out if:
- More children and young people with a good response to chemotherapy can be cured without having radiotherapy.
- Children and young people with more widespread classical Hodgkin lymphoma need less radiotherapy if they have intensive (stronger) chemotherapy.
There are several different treatment plans in this trial, allowing the treatment to be tailored to your needs. You are put into a risk group during the first two cycles of standard chemotherapy. The group you are in depends on 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. You are put into one of the following three groups:
Everyone in this trial has two cycles of OEPA chemotherapy (vincristine (sometimes known as Oncovin®), etoposide, the steroid prednisolone, and doxorubicin (Adriamycin®)) initially, followed by a PET scan to see how you responded to the treatment.
If you respond well to the treatment, you have more chemotherapy, but you do not have radiotherapy. If you are in the low-risk group you will receive one cycle of COPDAC-28. If you are in the intermediate or advanced groups, your chemotherapy is chosen at random by a computer (like tossing a coin) between:
- standard chemotherapy: COPDAC-28 (cyclophosphamide, vincristine (sometimes known as Oncovin®), prednisolone and dacarbazine, in a 28-day cycle)
- more intensive chemotherapy: DECOPDAC-21 (doxorubicin, etoposide, cyclophosphamide, vincristine (sometimes known as Oncovin®), prednisolone and dacarbazine, in a 21-day cycle).
Note that the dose of some of the drugs and how often you have them are different in the different regimens.
People in the intermediate group will have two cycles and people in the advanced group will have four cycles of one of these chemotherapies. The chemotherapy you have after your first PET scan is different to the chemotherapy you had for the first two cycles. Different chemotherapy is used to ‘mop up’ any remaining lymphoma cells.
If you are in the low-risk group and did not respond well to the first two cycles of OEPA chemotherapy then you will have radiotherapy, but no more chemotherapy. However if you are in the intermediate- or advanced-risk group and did not respond well to the OEPA treatment, then you will still have either the standard chemotherapy (COPDAC-28) or the more intensive chemotherapy (DECOPDAC-21). This is then followed by another PET-scan to determine how you responded to the additional chemotherapy and whether you will need additional radiotherapy.
If you need radiotherapy, the type of radiotherapy you have also depends on what group you are in and what chemotherapy you had.
- If you are in the low-risk group, you have standard radiotherapy.
- If you are in the intermediate or advanced group and had standard chemotherapy (COPDAC-28), you have standard radiotherapy.
- If you are in the intermediate or advanced group and had more intensive chemotherapy (DECOPDAC-21), you have less radiotherapy than usual.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
At least 2200 people are needed for this trial.
You may be able to enter if:
- You have classical Hodgkin lymphoma confirmed by biopsy.
- You are willing to use effective contraception during your treatment and for at least one year after treatment, if you are sexually active.
- You are under 25.
You won’t be able to enter if:
- You’ve had chemotherapy or radiotherapy for another cancer.
- You’ve had previous treatment for classical Hodgkin lymphoma, with the exception of steroids used to control a large tumour.
- You have nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL).
- You have another cancer as well as classical Hodgkin lymphoma.
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You can’t have any of the trial treatments.
- You have HIV.
- You live outside of the countries participating in this trial.
- You are pregnant or breastfeeding.
- You are taking part in another clinical trial or have been treated with an experimental treatment in the last 30 days.
More information about this trial is available at clinicaltrials.gov/ct2/show/NCT02684708.