CLARITY: a phase 2 trial using venetoclax and ibrutinib for chronic lymphocytic leukaemia that has come back or is not responding to treatment

Results from this trial have been published.

This trial is no longer recruiting participants.


Purpose of trial

The aim of the trial is to test whether combining ibrutinib with venetoclax is better than ibrutinib alone at treating chronic lymphocytic leukaemia (CLL) that has come back (relapsed) or is not responding to treatment (refractory).

Ibrutinib is already used to treat advanced CLL and although it helps, it doesn’t get rid of the CLL completely.


Treatments

Everyone in this study has a combination of two targeted treatments:

  • Ibrutinib – a cell signal blocker that targets and blocks a protein called BTK, which is important in survival of some lymphoma cells.
  • Venetoclax – that targets and blocks a protein important for survival of some lymphoma cells, called Bcl-2.

You take both of these drugs by mouth. You start with ibrutinib capsules for 8 weeks and then begin to take venetoclax tablets as well. Your doctor gradually increases the dose of venetoclax, as long as you aren’t having troublesome side effects.

Sometimes, with these types of treatment, CLL cells can be killed off quite rapidly and this leads to a temporary chemical imbalance in your blood. You have medication to prevent this and need to drink plenty of water to flush the chemicals away.

The study team would like to collect blood and bone marrow samples so you may have extra tests. They try to take extra blood at the same time that you are having blood samples taken anyway. They use these samples to find out more about CLL.

If the treatment is helping, you may be able to continue with it for up to 2 years. You have regular blood and bone marrow tests and if there are no CLL cells in either at any point, you stop the treatment.


Who can enter

This trial is no longer recruiting participants.


Further information

More information about this trial is available at Cancer Research UK.