STATIC: A study comparing intermittent and continuous treatment with ibrutinib in CLL/SLL

A phase 3 trial comparing intermittent and continuous treatment with ibrutinib in people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

You can share the following isrctn.com Identifier with your medical team so they can find out more about the trial: ISRCTN51675454

Trial aim and background 

Ibrutinib is a type of medication called targeted treatment. These treatments are designed to attack specific proteins on lymphoma cells. They are more precise than chemotherapy drugs leading to less immediate side effects but because they are taken for several years the side effects can become a problem. There is also some evidence that the longer ibrutinib is taken the more likely the CLL is to develop resistance to it.

This trial aims to find out whether having a treatment break from ibrutinib causes the following when compared to continuous treatment:

  • A reduction in the effectiveness of the medication 
  • A reduction in side effects
  • A reduction in the risk of resistance
  • Any change in the cost of treatment
  • Any impact on the patient’s emotional wellbeing

Participants will be randomly allocated into the control group who will receive the standard continuous regimen, or the experimental group who will have treatment breaks.

Who can enter

Adults over 18 with a diagnosis of CLL or SLL who have been treated with ibrutinib as their second or subsequent treatment on the NHS, or as part of another trial called the FLAIR trial may be eligible to apply for this trial.

Locations

Recruitment will take place at St James's Hospital, Leeds

Further information

More information about what treatments are involved, the criteria you must meet in order to take part in the trial and where this trial is taking place are available at: https://www.isrctn.com/ISRCTN51675454

Lymphoma Action are not able to refer people to specific trials. If you are interested in taking part in this trial we recommend that you print the trial summary and discuss it with your medical team. They can advise you on whether you might be eligible for the trial and how you can take part based on your individual circumstances.