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Mangrove: A phase 3 trial of zanubrutinib plus rituximab in older people with untreated mantle cell lymphoma

This trial is testing a new treatment called zanubrutinib, combined with rituximab, in people over 65 with mantle cell lymphoma who have not been treated before.


Purpose of trial

The aim of this trial is to find out whether zanubrutinib plus rituximab is as safe and effective as current treatment for older people with untreated mantle cell lymphoma.


Treatments

People who take part in this trial are put into one of two treatment groups at random:

  • People in group 1 have zanubrutinib plus rituximab.
  • People in group 2 have bendamustine plus rituximab.

You can’t choose which treatment you have and neither can your doctor. You are told which treatment you are having and given information about it.

Zanubrutinib is a targeted treatment that blocks a protein called Bruton’s tyrosine kinase (BTK). This interferes with signals that keep B cells alive and make them divide. B cells are the type of white blood cell that are abnormal in mantle cell lymphoma. Interfering with their signalling pathways can prevent the cells from dividing or make them die.

Zanubrutinib is a capsule that you take by mouth twice a day. If you are in group 1, you carry on taking it unless you stop responding to it or you develop serious side effects.
You have it as a capsule that you take by mouth twice a day. You carry on taking it unless your lymphoma gets worse or you develop side effects you can’t cope with.

Rituximab is an antibody treatment already widely used to treat people with non-Hodgkin lymphoma. You have it through a drip into a vein on day 1 of each 21-day cycle. You have up to six cycles.

Bendamustine is a chemotherapy drug. You have it through a drip into a vein on days 1 and 2 of each 21-day cycle. You have up to six cycles.


Who can enter

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

Around 500 people are needed for this trial.

You may be able to enter if:

  • You have mantle cell lymphoma.
  • You have not been treated for your lymphoma before.
  • 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 are either:
  • You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.

You won’t be able to enter if:

  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You are due to have a stem cell transplant after your initial course of treatment.
  • You are being treated for an infection.
  • You have significant heart disease or a serious bleeding disorder.
  • You have an illness that affects how well you are able to digest food.
  • You can’t swallow capsules.
  • You are taking certain other drugs that might interfere with the study treatment.
  • You have been treated with the trial drugs, or other similar drugs, before.

Further information

More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT04002297