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PembroWM: a phase 2 trial of rituximab and pembrolizumab in people with relapsed or refractory Waldenström’s macroglobulinaemia

This trial is testing rituximab and pembrolizumab in people with Waldenström’s macroglobulinaemia that has come back (relapsed) or not responded (refractory) after previous treatment.


Purpose of trial

The aim of this trial is to find out whether a combination of rituximab and pembrolizumab is safe and effective at treating people with Waldenström’s macroglobulinaemia that has come back (relapsed) or not responded (refractory) after previous treatment.


Treatments

Everybody in this trial is treated with rituximab and pembrolizumab.

  • Pembrolizumab is a type of targeted drug called a checkpoint inhibitor. It helps your immune system recognise and destroy lymphoma cells.
  • Rituximab is an antibody therapy. It sticks to a protein called ‘CD20’ on B cells. This attracts immune cells, which can kill the B cells.

You have both the drugs through a drip into a vein. You have pembrolizumab once every 3 weeks for up to a year. You have up to eight doses of rituximab.


Who can enter

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

Around 42 people are needed for this trial.

You may be able to enter if:

  • You have Waldenström’s macroglobulinaemia.
  • Your lymphoma is measurable by the tests used in the trial.
  • You have previously had at least one course of treatment for your lymphoma.
  • 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 not pregnant.
  • You are 18 or over.

You won’t be able to enter if:

  • Your lymphoma got worse during rituximab treatment or within 6 months of stopping rituximab treatment.
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have been treated with pembrolizumab or a similar drug before.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You’ve had surgery in the last 4 weeks.
  • You’ve had cancer treatment (except skin-directed therapy or BTK inhibitors such as ibrutinib) within the last 4 weeks.
  • You’ve had an antibody therapy that reduces your T cells (such as Campath) in the last 3 months.
  • You’ve ever had a donor (allogeneic) stem cell transplant.
  • You have HIV, hepatitis C, hepatitis B or any infection that needs treatment.
  • You have another cancer that needs active treatment, except certain localised cancers.
  • You have any conditions that might make it difficult for you to follow the instructions involved in the trial.
  • You’ve had serious heart disease in the last 6 months.
  • You’ve had a stroke or bleeding on your brain in the last 6 months.
  • You have any serious medical condition that is not controlled by medication.
  • You have an illness that dampens your immune system, or you are taking medicines that dampen your immune system.
  • You have an autoimmune disease, except certain conditions that are controlled by medication or skin conditions that are controlled by skin-directed treatments.
  • You’ve ever had anaemia caused by your red blood cells being destroyed (haemolytic anaemia).
  • You’ve ever had lung inflammation that needed steroid treatment.
  • You’ve had a live vaccine in the last 30 days.
  • You are pregnant or breastfeeding.
  • You are planning to become pregnant or to make your partner pregnant while you are on the study treatment or within 4 months of finishing the study treatment.
  • You’ve had any experimental treatment in the last 4 weeks.
  • You’re having treatment as part of another clinical trial.
  • Any of the study drugs are not suitable for you.

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03630042