Purpose of trial
This trial has two parts.
- Part 1 is for children and young people up to 18 years old with B-cell non-Hodgkin lymphoma and is testing if ibrutinib behaves in the same way in children as it does in adults. It also aims to confirm the dose of ibrutinib to be used for part 2.
- Part 2 is for children and young adults up to 30 years old who were first diagnosed with B-cell non-Hodgkin lymphoma when they were under 18. This part of the trial is testing the safety and effectiveness of ibrutinib in combination with chemo-immunotherapy (chemotherapy with rituximab antibody therapy).
Part 1 of this trial is now closed, but part 2 is continuing to recruit participants.
Non-Hodgkin lymphoma (NHL) can develop from a B lymphocyte (B-cell NHL) or a T lymphocyte (T-cell NHL). B-cell NHL is much more common than T-cell NHL. Only people with a B-cell NHL are eligible for this trial.
Standard treatment for B-cell NHL is usually very successful in children and young adults. However, B-cell NHL that has relapsed (come back) or was refractory (didn’t respond) to previous treatment is difficult to treat successfully. Ibrutinib is a drug already used to treat lymphoma in adults. This trial is testing whether adding it to standard chemo-immunotherapy can improve outcomes for children and young adults with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
Everyone in this trial has standard chemo-immunotherapy. Your doctor can choose one of two chemo-immunotherapy regimens (combinations of drugs):
- RICE: rituximab, ifosfamide, carboplatin, and etoposide
- RVICI: rituximab, vincristine, ifosfamide, carboplatin, and idarubicin.
People enrolled in part 2 are randomised to one of two groups:
- standard chemo-immunotherapy alone
- ibrutinib with standard chemo-immunotherapy.
The chemo-immunotherapy is given intravenously (into a vein). Ibrutinib is taken orally (by mouth) as capsules or suspension (liquid).
You can’t choose whether or not you have ibrutinib and nor can your doctor. You are told what treatment you are having and given information about it.
Each cycle of treatment is 28 days and three cycles of chemo-immunotherapy or ibrutinib with chemo-immunotherapy are given. Patients who take ibrutinib and respond to treatment (lymphoma reduces significantly) may be given up to three more cycles of treatment with ibrutinib alone as long as it is still helping.
Who can enter
The trial team can advise you whether you/your child is suitable for this trial and whether there may be any other conditions or treatments that you/they have or have had that would prevent trial entry.
Up to 96 people are needed for this trial.
You may be able to enter if:
- You have a B-cell NHL.
- Your lymphoma has relapsed after your first treatment (you can’t take part if you’ve had more than one relapse) or your lymphoma didn’t respond to your first treatment.
- Your lymphoma is measurable with the tests used in the trial.
- Your doctor thinks you are well enough to take part in the trial.
- You are up to age 30 and were first diagnosed with B-cell NHL when you were under 18 (part 2).
You won’t be able to enter if:
- You are taking certain blood-thinning medicines or any other medicine that might interfere with the trial treatments. The trial team can advise if this applies to you.
- You have a condition that makes you more likely to have abnormal bleeding.
- You have significant heart problems.
- You have HIV, hepatitis B or hepatitis C.
- You have a digestive condition that means you might not properly absorb the trial treatment.
- You have known allergy to the trial drugs or these drugs are otherwise not suitable for you.
- You have post-transplant lymphoproliferative disease (PTLD) due to an organ transplant.
- You have had an allogeneic (donor) stem cell transplant in the last 6 months.
- You are pregnant or breastfeeding or unwilling to use appropriate contraception if you are sexually active.
More information about this trial is available at www.clinicaltrials.gov/ct2/show/NCT02703272.