Purpose of trial
The main aim of this trial is to see if adding ibrutinib to rituximab can extend the amount of time where lymphoma is kept under control.
A second part of the trial is testing whether the lymphoma remains under control if ibrutinib is stopped after 2 years of treatment.
Rituximab is a monoclonal antibody. It is widely used as a treatment for follicular lymphoma, both alone and in combination with chemotherapy.
Ibrutinib is a cell signal blocker. It blocks signals that encourage leukaemia cells to grow. It is already used to treat some types of lymphoma.
This is a randomised trial. Participants are put into one of the following groups at random:
- rituximab with ibrutinib
- rituximab with placebo (a dummy treatment).
You can’t choose which group you are in and neither can your doctor. Neither you nor your doctor will know whether you are having ibrutinib or placebo.
Rituximab is given intravenously (into a vein). Ibrutinib is taken as capsules by mouth.
Everyone in this trial has rituximab once a week for 4 weeks. This is followed by maintenance (treatment to keep lymphoma under control) where you have rituximab once every 2 months for up to 2 years. Everyone takes ibrutinib or placebo capsules every day for up to 2 years.
You stop treatment if your lymphoma gets worse or you develop side effects bad enough to have to stop it. If you have to stop the trial treatment, your doctor can discuss your treatment options with you.
If you are in the ibrutinib group and you are still taking ibrutinib after 2 years, you are randomised again to decide if:
- you continue to take ibrutinib
- you take a placebo instead.
Again, you and your doctor will not know whether you are having ibrutinib or placebo.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 440 people are needed for this trial.
You may be able to enter if:
- You have follicular lymphoma (grade 1, 2 or 3a ).
- Your follicular lymphoma is stage 2, 3 or 4.
- A sample of the lymphoma is available for tests or you are willing to have a fresh sample taken.
- Your lymphoma is measurable with the tests used in the trial.
- You have risk factors (Groupe d’Etude des Lymphomes Folliculaire [GELF] criteria) that mean you need immediate treatment for your follicular lymphoma.
- You are well enough to have the trial treatments.
- Your blood and health test results are satisfactory.
- You are 70 or over or 60–69 with health conditions that limit your treatment options.
You will not be able to enter if:
- Your follicular lymphoma is grade 3b.
- Your lymphoma has transformed (changed) into a faster-growing type of lymphoma.
- You have chronic lymphocytic leukaemia (CLL).
- You have had previous treatment for follicular lymphoma.
- Your lymphoma is affecting your central nervous system (CNS; brain and spinal cord).
- You have significant heart problems.
More information about this trial is available at clinicaltrials.gov.