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BRUIN-CLL-321: A phase 3 trial of a targeted treatment called pirtobrutinib in people with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

This trial is comparing pirtobrutinib with standard treatment options in people with CLL/SLL that has come back or not responded after at least one previous course of treatment.


Purpose of trial

The aim of this trial is to compare the efficacy of pirtubrutinib with existing treatment options in people with relapsed or refractory CLL/SLL.


Treatments

People who take part in this trial are randomly allocated to one of two treatment groups:

  • People in group 1 have pirtobrutinib (also known as LOXO-305).
  • People in group 2 have their doctor’s choice of either idelalisib plus rituximab or bendamustine plus rituximab.

You can’t choose which group you are in and neither can your doctor. You will be randomly assigned to group 1 or 2 and will be told which treatment you are having and given information about it.

Pirtobrutinib is a targeted treatment that blocks a protein called ‘BTK’ on B cells (the type of white blood cells that become abnormal in CLL/SLL). BTK is part of a pathway that helps B cells to stay alive and divide. Blocking BTK can make B cells die or prevent them dividing. If assigned to group 1, you will have pirtobrutinib as tablets that you take by mouth every day. You carry on taking it unless your CLL or SLL gets worse or you develop troublesome side effects.

Idelalisib is a targeted treatment that blocks a protein called ‘PI3K’ on B cells. PI3K is also part of a pathway that helps B cells to stay alive and divide. Blocking PI3K can make B cells die or prevent them dividing. You have idelalisib as a tablet that you take by mouth twice a day. You carry on taking it unless your CLL or SLL gets worse or you develop troublesome side effects.

Bendamustine is a chemotherapy drug. You have it through a drip into a vein for six cycles of treatment.

Rituximab is an antibody therapy that blocks a protein called CD20 on B cells. This stimulates your immune system to destroy the cells. You have it through a drip into a vein for six cycles of treatment.


Who can enter

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

Around 250 people are needed for this trial.

You may be able to enter if:

  • You have CLL or SLL that requires treatment.
  • You have previously had at least one course of treatment for your CLL or SLL. This must have included another BTK inhibitor (such as ibrutinib, acalabrutinib or zanubrutinib).
  • You are well enough to take part in the trial.
  • Your blood counts and other blood tests are satisfactory.
  • Your liver and kidneys are working well enough to take part in the trial.
  • 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:

  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have CLL/SLL in your central nervous system (CNS; brain and spinal cord).
  • Your CLL/SLL has changed to a faster-growing type of blood cancer (Richter transformation).
  • You have low blood counts caused by your immune system mistakenly attacking your own cells.
  • You have been treated with a similar drug before.
  • You’ve had a stem cell transplant or CAR T-cell therapy in the last 60 days.
  • You have an active infection.
  • You have HIV, hepatitis B, hepatitis C or cytomegalovirus (CMV) infection.
  • You have an illness that means you can’t absorb food properly.
  • You have liver damage caused by any medication you’ve had in the past.
  • You have serious heart disease.
  • You are taking certain medication to thin your blood.
  • You are taking certain other drugs that might interfere with the study treatment.
  • You’ve had a live vaccine in the last 28 days.
  • You are pregnant or breastfeeding.
  • Any of the study drugs are not suitable for you.
  • You’ve had a bad reaction to rituximab in the past.

Further information

More information about this trial is available at https://clinicaltrials.gov/ct2/show/NCT04666038