Purpose of trial
The aim of this study is to see if the combination of ibrutinib and obinutuzumab is safe and effective for people with chronic lymphocytic leukaemia (CLL) that has come back (relapsed) or didn’t respond to previous treatment (refractory disease). Ibrutinib and obinutuzumab are both already used to treat some people with CLL, but researchers want to test whether combining these drugs can improve outcomes.
This is a feasibility study, which means the combination of drugs is being tested in a small number of people at first. A larger trial will be designed if the results of this study show that this combination is safe and effective.
Everyone who takes part in this trial has ibrutinib and obinutuzumab. Ibrutinib is a cell signal blocker. It blocks signals that encourage leukaemia cells to grow. Obinutuzumab is an antibody treatment.
You take ibrutinib as capsules orally (by mouth) every day. You continue taking ibrutinib as long as your CLL does not get worse and you don’t have side effects bad enough to make you want to stop it.
You have obinutuzumab intravenously (into a vein). A small amount of the drug is given first at a slow infusion rate to begin with. The rest of the dose may be given later the same day or the following day. The infusion rate may be increased gradually. You have two more infusions in the first month of treatment and then have one infusion a month for up to 9 doses in total.
You have blood tests and bone marrow tests during the trial to see how well the treatment is working.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 40 people are needed for this trial.
You may be able to enter if:
- You have CLL.
- Your specialist thinks your CLL needs to be treated.
- Your CLL has relapsed or was refractory to previous treatment.
- You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
- You and your partner are willing to use reliable contraception during treatment and for at least 18 months after treatment if there is any chance of you or your partner becoming pregnant.
- Your blood and other health test results are satisfactory.
- You are 18 or over.
You will not be able to enter if:
- Your CLL has transformed into Richter’s syndrome. You have prolymphocytic leukaemia or mantle cell lymphoma.
- Your CLL is in your central nervous system (CNS; brain and spinal cord).
- You have very low blood counts that are not due to your CLL.
- You have problems with red blood cells (haemolysis) that are not being controlled by medication.
- You have HIV, hepatitis C virus or hepatitis B virus.
- You have had major surgery in the last 4 weeks.
- You have serious heart problems.
- You have had progressive multifocal leukoencephalopathy (a life-threatening brain infection).
- You have an infection.
- You have had another cancer, except certain localised cancers.
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You’ve had a severe allergic reaction to antibody treatment in the past or are allergic to any of the components of the study drugs.
- You have had a live vaccine in the 4 weeks before starting trial treatment.
- You have had blood thinning drugs, eg warfarin, in the 7 days before starting ibrutinib.
- You are taking certain other drugs that might interfere with the study treatment.
- You have had another experimental drug in the last 6 weeks.
- You are pregnant or breastfeeding.
More information about this trial is available at Cancer Research UK.