Update on the HR-NBL2 chemoimmunotherapy arm for refractory neuroblastoma
The chemoimmunotherapy arm of the HR-NBL2 clinical trial for children whose high-risk neuroblastoma has not responded adequately to initial treatment has been closed to all new patients. This follows the identification of unexpected toxicities within the protocol that require further investigation.
This change relates specifically to the chemoimmunotherapy arm for refractory patients. It does not mean that the whole HR-NBL2 trial has closed.
This page explains what has changed and answers some common questions. If you have questions about your child's treatment or what the change means for your child, please speak with your child's consultant or clinical team. They are best placed to advise you about your child's individual care.
Solving Kids' Cancer UK's Family Support Team can provide emotional and practical support and help you prepare for conversations with your clinical team.
If you have urgent questions about your child's treatment: Please contact your child's consultant or clinical team directly. Solving Kids' Cancer UK cannot provide clinical advice or recommend treatment.
Further information
Questions and answers
What has changed?
The chemoimmunotherapy arm of HR-NBL2 used for some children with refractory neuroblastoma has been closed to all new patients. This follows the identification of unexpected toxicities within the protocol that require further investigation.
Why has the arm been closed?
The closure is a safety measure while the unexpected toxicities are investigated. Families should discuss child-specific questions with their treating clinical team.
Does this mean the whole HR-NBL2 trial has closed?
No. The change relates specifically to the chemoimmunotherapy arm for refractory patients. Your child's clinical team can explain whether any other part of HR-NBL2 remains relevant to your child's treatment pathway.
Can a new patient still join the chemoimmunotherapy arm?
No. The chemoimmunotherapy arm is closed to all new patients.
Will the chemoimmunotherapy arm reopen?
No. The chemoimmunotherapy arm will not reopen. Other treatment approaches may be considered by the clinical team depending on a child’s individual circumstances.
If a child has refractory disease, do they come off the HR-NBL2 trial?
If a child does not respond adequately to induction treatment and requires treatment for refractory disease, they will come off HR-NBL2 and receive treatment outside the clinical trial. Their future treatment options will be determined by their treating team, informed by specialist advice where appropriate.
Can a child re-enter HR-NBL2 after treatment for refractory disease?
No. If a child comes off HR-NBL2 to receive treatment for refractory disease, they cannot subsequently re-enter the trial. Children may still receive treatment that is the same as, or similar to, elements of the HR-NBL2 pathway, but this would be delivered outside the trial context. Your child's consultant can explain what this means for your child's treatment plan.
What happens to children who were already receiving treatment on this arm?
Families of children who were already receiving treatment on the arm should discuss their individual situation with their treating consultant. The clinical team will review the child's circumstances and advise on the most appropriate next steps, informed by specialist advice where appropriate.
My child has refractory disease and might have been considered for this arm. What happens now?
Your child's clinical team will consider the individual circumstances and the possible next steps. The team may seek specialist advice through the National Neuroblastoma Advisory Panel, known as NNAP.
What is the National Neuroblastoma Advisory Panel (NNAP)?
NNAP is a specialist multidisciplinary panel that discusses individual neuroblastoma cases and provides guidance to the child's treating consultant. The consultant remains responsible for discussing the panel's advice and possible treatment options with the family.
What other treatment options may be available?
Treatment options depend on the individual child. Your child's consultant and clinical team are best placed to discuss which options may be available and appropriate. Solving Kids' Cancer UK cannot recommend a treatment or advise whether a child should take part in a clinical trial.
When will more information be available?
The unexpected toxicities are being investigated through the appropriate clinical and trial processes. Further information should be communicated through the relevant clinical and trial channels when it is available. Families should speak with their child's consultant about any updates relevant to their child's care.
Where can families go for help?
For clinical questions, individual risk and treatment decisions, please contact your child's consultant or clinical team. Solving Kids' Cancer UK's Family Support Team can provide emotional and practical support, help you prepare questions for appointments and support you through conversations and decisions with your clinical team.
Questions you may wish to ask your clinical team
Many families find it helpful to prepare questions before an appointment. You may wish to ask:
- What does the closure of this arm mean for my child specifically?
- Has my child's case been referred to, or discussed by, NNAP?
- If not, will specialist advice be sought and how quickly can this happen?
- When should we expect feedback following any NNAP discussion?
- Could the time needed to obtain specialist advice affect my child's treatment timing?
- What treatment options are now being considered?
- Why are these options being considered for my child?
- What are the potential benefits, risks and uncertainties of each option?
- Are any additional tests or assessments needed before a decision is made?
- How quickly can the possible treatment options be started?
- Will treatment be provided at our current hospital, or might we need to travel to another centre?
- What should we expect over the coming days and weeks?
- When will we next speak about the treatment plan?
- Who should we contact if we have further questions or if our child's condition changes?
Support from Solving Kids' Cancer UK
We understand that changes to treatment plans can be worrying and may create uncertainty for families.
While we cannot provide clinical advice or recommend treatment, our Family Support Team can:
- provide emotional support
- help you prepare questions for appointments
- help you work through information provided by your clinical team
- provide practical support and signposting where appropriate
- support you before and after discussions with your clinical team
Contact the Family Support Team via email: support@solvingkidscancer.org.uk, or telephone 0207 284 0800.