MAGNOLIA: a phase 2 open-label study of zanubrutinib in people with relapsed or refractory marginal zone lymphoma

This trial is testing a targeted drug called zanubrutinib (also known as BGB-3111) in people with marginal zone lymphoma (extranodal marginal zone lymphoma [MALT lymphoma], nodal marginal zone lymphoma or splenic marginal zone lymphoma) that has come back (relapsed) or not responded (refractory) after previous treatment.


Purpose of trial

The aim of this trial is to find out if zanubrutinib is safe and effective for people with relapsed or refractory marginal zone lymphoma.


Treatments

All participants in the study are treated with zanubrutinib. You take it orally (by mouth) as capsules twice a day. You continue taking it for as long as it is benefitting you.

Zanubrutinib is a cell signal blocker that works by interfering with signals that keep B cells alive and make them divide. B cells are the type of white blood cell that are abnormal in marginal zone lymphomas. Interfering with the cells’ signals can prevent them from dividing or make them die.


Who can enter

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

Around 65 people are needed for this trial.

You may be able to enter if:

  • You have marginal zone lymphoma (including nodal marginal zone lymphoma, extranodal marginal zone [MALT] lymphoma or splenic marginal zone lymphoma).
  • You have previously had at least one course of treatment for your lymphoma, including antibody therapy (on its own or combined with chemotherapy).
  • Your doctor thinks you need systemic (whole body) treatment for your lymphoma.
  • 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 reliable contraception 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:

  • Your lymphoma has transformed (changed) to a more aggressive type.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have heart disease or severe lung disease.
  • You have HIV, hepatitis C or hepatitis B.
  • You have had another cancer in the last 2 years, except certain localised cancers.
  • You are being treated for an infection.
  • You’ve ever had a severe bleeding disorder, bleeding in your brain or spontaneous bleeding that needed a blood transfusion or other treatment.
  • You’ve had major surgery in the last 4 weeks.
  • You have been treated with a drug that’s similar to the study drug before.
  • You are taking certain other drugs that might interfere with the study treatment.
  • You are taking part in another clinical trial.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03846427

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