Purpose of trial
The aim of the trial is to find the best dose of idelalisib for treating follicular lymphoma that has come back or has not responded to treatment. The researchers also want to find out more about the side effects (unwanted treatment effects) of each dose.
In this trial, the researchers are testing idelalisib in follicular lymphoma that has started to grow again (relapsed) after at least 2 previous courses of treatment, or has not responded to those treatments (refractory).
This is a randomised trial. Participants are randomised to receive 200mg or 300mg of idelalisib a day. You can’t choose which dose you have and neither can your doctor. Neither you nor your doctor is told what dose you are having. Your doctor is able to find out what dose you are taking if they need to do so during the study.
Idelalisib is a type of treatment called a cell signal blocker. It blocks signals that B cells send to help them stay alive and divide. It comes as a tablet, which you take twice a day. Each tablet is either 100mg or 150mg.
After 8 weeks, the researchers check how your lymphoma is responding to treatment and you may:
- stop the drug
- stay on the same dose
- increase your dose if you are on the lower dose.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 240 people are needed for this trial.
You may be able to enter if:
- You have B-cell follicular lymphoma that is grade 1, 2 or 3a and stage 2, 3 or 4.
- Your lymphoma is measurable on a scan.
- You have had at least 2 previous types of treatment and these are no longer controlling your lymphoma.
- Your lymphoma started to grow again within 6 months of your last treatment.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- Your blood and other health test results are satisfactory.
- You agree to all the tests and scans in the study and to take medicine to prevent pneumonia.
You will not be able to enter if:
- You have had any type of lymphoma apart from follicular lymphoma.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have a condition called myelodysplastic syndrome.
- You have ever had a serious allergic reaction.
- You have had another cancer.
- You have or have had lung inflammation caused by a drug.
- You have any type of infection at the time of joining the trial or have had an infection called CMV in the past 28 days.
- You have or have had any type of liver disease or inflammatory bowel disease.
- You have been treated with a similar drug before.
- You are taking drugs to damp down your immune system, including steroids, unless these are for certain conditions.
- You have had a stem cell or organ transplant in the past.
- You have HIV, hepatitis C virus or hepatitis B virus.
- You are pregnant or breastfeeding.
- You are taking part in another clinical trial.
More information about this trial is available at clinicaltrials.gov.