Purpose of trial
The aim of this trial is to find out whether children and young people:
- who have had all their lymphoma removed by surgery need to have chemotherapy
- with lymphoma remaining after surgery can safely have less chemotherapy than they would commonly get.
Treatment for nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) is already successful, but children and young people tend to receive treatments used for a more aggressive type of Hodgkin lymphoma. Some of these treatments may cause health problems later in life (late effects).
Current evidence suggests that NLPHL in children and young people can be treated successfully with less chemotherapy or, in some cases, without any chemotherapy at all. Giving less chemotherapy can lower the risk of late effects.
Everyone in this trial has surgery to remove the main lymph node(s) containing NLPHL.
Following the surgery, there are 2 trial groups:
- If all the NLPHL has been removed, there is no further treatment. Participants need to have regular check-ups to monitor their progress. If participants need any more treatment, their doctor will choose the best treatment for them.
- If there is some NLPHL left after surgery, and if this residue cannot be removed by additional surgery participants are given a low dose chemotherapy regimen (combination of drugs) called CVP.
CVP is made up of:
The treatment consists of 3 courses (cycles) of the CVP and each of these courses lasts for 2 weeks.
Cyclophosphamide and vinblastine are given intravenously (through a drip into a vein) and the steroid drug prednisolone is taken as a tablet.
During each of the 3 cycles of CVP:
- cyclophosphamide is given on the first day
- vinblastine is given on the first and eighth day
- prednisolone is taken every day for the first eight days of each course.
After the treatment has finished, all participants in this study have regular appointments with the doctors to check on their well-being. They need to attend these appointments for at least 5 years.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you/your child.
Around 200 people are needed for this trial.
You may be able to enter if:
- You have nodular lymphocyte-predominant Hodgkin’s lymphoma (confirmed by biopsy).
- You have lymphoma stage 1A or 2A disease.
- You are under 18.
You will not be able to enter if:
- You’ve already had chemotherapy or radiotherapy.
- You have higher stage (more widespread) NLPHL.
- You’ve had steroids in the last 30 days.
- You had, or still have, another type of cancer or any other serious medical condition.
- You’ve taken part in an investigational clinical trial in the past 30 days.
- You have HIV.
- You are pregnant or breastfeeding.
- You have known sensitivity to study drugs or these drugs are otherwise not suitable for you.
- You don’t want to use appropriate contraception (as per trial requirements).
More information about this trial is available at clinicaltrials.gov.