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BGB-3111-212: a randomised phase 2 trial to see if adding zanubrutinib (BGB-3111) to obinutuzumab can improve outcomes for people with follicular lymphoma who have had previous treatment

This trial is testing a new drug for people with follicular lymphoma who have had at least two courses of treatment but need more treatment.


Purpose of trial

The aim of this trial is to compare the safety and effectiveness of:

  • obinutuzumab alone
  • obinutuzumab with a new, targeted drug, zanubrutinib (also called BGB-3111).

Treatments

Obinutuzumab is an antibody treatment that works in a similar way to rituximab and is approved to treat some people with follicular lymphoma. It binds (sticks) to B cells (a type of white blood cell that becomes cancerous in follicular lymphoma). Your immune system can then destroy the B cells. 

BGB-3111 is a cell signal blocker that works by interfering with B cell signalling. Interfering with the cells’ signals can prevent them from dividing or make them die.

There are two treatment groups in this trial:

  • obinutuzumab alone
  • obinutuzumab and zanubrutinib.

You are randomised (randomly assigned a group by computer) to decide which group you are in. One out of every three people in the trial has obinutuzumab alone and two out of every three people have both obinutuzumab and zanubrutinib. You can’t choose which group you are in, but you are told which treatment you are receiving and given information about it.

Everyone in the trial has obinutuzumab intravenously (into a vein). You have it in cycles, where a cycle is 4 weeks (28 days) long.

  • For the first cycle, you have obinutuzumab once a week for 3 weeks, followed by a week without treatment. 
  • For the next five cycles, you have obinutuzumab once every 4 weeks. 

After you have had six cycles of treatment, you might be able to have obinutuzumab once every 2 months as a maintenance treatment for up to 2 years. This might keep your lymphoma under control (in remission) for longer by ‘mopping up’ any remaining lymphoma cells that can’t be detected on tests. 

If you are also having zanubrutinib, you take it orally (by mouth) as capsules twice a day. You can continue this treatment for as long as your doctor thinks it is benefitting you. 

If you are having only obinutuzumab and your lymphoma gets worse (progressive disease) at any time or if you do not respond within 12 cycles, then your doctor might be able to add zanubrutinib to your treatment if they think this is the best treatment option for you.  


Who can enter

Your consultant can give you advice on whether you might be suitable for this trial.

Approximately 210 people are needed for this trial.

You may be able to enter if:

  • You have follicular lymphoma.
  • A sample of your biopsy is available for tests.
  • You have previously had at least two courses of treatment for your lymphoma.
  • Your previous treatment included an antibody targeting CD20, for example rituximab, and chemotherapy.
  • You did not respond well to your last treatment (refractory lymphoma) or your lymphoma has got worse (relapsed).
  • Your lymphoma is measurable by the tests used in the trial.
  • You are well enough to take part in the trial.
  • Your blood and other health test results are satisfactory.
  • You and your partner are willing to use effective contraception during the trial and for 18 months after finishing obinutuzumab and 90 days after finishing zanubrutinib if there is any chance of you or your partner becoming pregnant.
  • You are 18 or over.

You won’t be able to enter if:

  • You’ve been treated with ibrutinib or a similar drug (a BTK inhibitor) before.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • Your lymphoma has transformed (changed) into a faster-growing type of lymphoma.
  • You’ve had another cancer in the last 5 years, unless it was certain localised cancers.
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment, for example heart problems, lung problems or problems with severe bleeding.
  • You’ve had a stroke or bleeding on your brain in the last 6 months.
  • You have HIV or active hepatitis B or hepatitis C.
  • You can’t swallow capsules or you have digestive problems that might make it difficult for you to absorb the treatment.
  • You’ve had major surgery or injury in the last 4 weeks.
  • You’ve had a donor (allogeneic) stem cell transplant in the last 12 months.
  • You are taking certain medications that affect cytochrome P450 subtype CYP3A (enzymes in your body) – your doctor can advise if this applies to you.
  • You’ve had a live vaccine in the last 35 days.
  • You have had a bad reaction to one of the trial drugs or their ingredients in the past.
  • You are taking part in another clinical trial that involves treatment.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at www.clinicaltrials.gov/ct2/show/NCT03332017