Purpose of study
The aim of the study is to develop tests that tell doctors in advance who is likely to respond to treatment with ibrutinib and who isn’t.
The researchers test blood and bone marrow samples for substances (biomarkers) that may show that the disease is not likely to respond to ibrutinib (resistant).
In the last stage of the study, the researchers crosscheck the results of the biomarker studies with how well each person did on treatment. This helps to check if the biomarkers are useful (validation).
What is involved
You have to be having ibrutinib as part of your regular treatment to take part. Your doctor asks your permission to send the treatment centre samples of your:
- bone marrow
The samples are taken at the same time as you are having regular tests, so you don’t have to have extra procedures.
The trial team collects your samples for research for 2 years after you join the trial. In addition to these samples, the study team ask your doctor for information from your medical notes about how your treatment is going and how you are doing for at least 2 years.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 120 people are needed for this trial.
You may be able to enter if:
- You have CLL or mantle cell lymphoma.
- You are having or are about to start treatment with ibrutinib.
More information about this trial is available at clinicaltrials.gov.