Purpose of trial
The aim of this trial is to compare the safety and effectiveness of ibrutinib and a new, targeted drug BGB-3111 for people with Waldenström’s macroglobulinaemia (WM) who have had previous treatment or who are not suitable for standard chemoimmunotherapy (chemotherapy with antibody treatment).
Participants in this trial have bone marrow samples taken to assess whether their lymphoma cells have mutations (changes) in a gene called ‘MYD88’.
Ibrutinib is a cell signal blocker. It targets Bruton’s tyrosine kinase (BTK), which is part of a pathway that helps B cells to stay alive and divide (multiply). Ibrutinib is already approved for treating some people with WM.
BGB-1111 is a more selective BTK inhibitor than ibrutinib. It is being tested to see if it is as effective as ibrutinib with fewer side effects.
People with MYD88 mutations are randomised to receive either:
- BGB-3111 twice a day (Arm A)
- ibrutinib once a day (Arm B).
People without MYD88 mutations take BGB-3111 twice a day (Arm C). Both treatments are taken orally (by mouth) every day as long as the treatment is helping you.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 210 people are needed for this trial.
You may be able to enter if:
- You have Waldenström’s macroglobulinaemia (WM) confirmed by histology (examination of cells under a microscope).
- You need treatment for WM.
- If you haven’t already had treatment for WM, you can only enter if you can’t have standard chemoimmunotherapy.
- Your WM is measurable by the tests used in the trial.
- You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
- Your bone marrow, liver, kidney and heart function are satisfactory.
- You and your partner are willing to use reliable contraception during the trial and for at least 90 days after the last dose of trial treatment if there is any chance of you or your partner becoming pregnant.
You will not be able to enter if:
- You have been treated with a similar drug before.
- Your WM has transformed (changed) into a faster-growing type of lymphoma.
- You have had other anticancer treatment recently, including steroids in the last 7 days, chemotherapy or radiotherapy in the last 3 weeks or antibody treatment in the last 4 weeks.
- You have had major surgery in the last 4 weeks.
- You still have significant side effects from your previous treatment.
- You have had an autologous stem cell transplant in the last 3 months or an allogeneic stem cell transplant in the last 6 months.
- You have had another cancer in the last 2 years, except certain localised cancers.
- You have significant heart problems.
- You are unable to swallow capsules or have digestive problems that mean you might not properly absorb the trial treatment.
- You have an infection or recently had an infection that required intravenous antibiotics.
- You have HIV, hepatitis B or hepatitis C.
- You are pregnant or breastfeeding.
- You have any other condition that your doctor thinks might make it unsafe for you to take part in the trial.
- You are taking certain medications that affect cytochrome P450 or CYP3A – your doctor can advise if this applies to you.
More information about this trial is available at clinicaltrials.gov.