Purpose of trial
Ibrutinib with placebo (a dummy drug) is compared with ibrutinib with venetoclax:
- to find out if adding venetoclax to ibrutinib is safe for people with mantle cell lymphoma
- to find out if adding venetoclax to ibrutinib can keep lymphoma under control for longer.
Ibrutinib is a cell signal blocker. It blocks signals that encourage cancer cells to grow. It is already used on its own to treat some people with relapsed or refractory mantle cell lymphoma.
Venetoclax targets and blocks a protein important for survival of some lymphoma cells, called Bcl-2. It is used for other types of blood cancer, such as chronic lymphocytic leukaemia (CLL) .
In this trial, participants are randomly assigned to one of two treatment groups:
- ibrutinib and placebo
- ibrutinib and venetoclax.
You can’t choose which treatment you have and neither can your doctor. The placebo drug looks the same as venetoclax, so you and your doctor cannot tell which treatment group you are in. You are given information about all treatments in the trial.
All the drugs and placebo are taken orally (by mouth) as capsules or tablets once every day that you are in the trial. You continue taking the treatment for as long as it is benefiting you.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 287 people are needed for this trial.
You may be able to enter if:
- You have mantle cell lymphoma confirmed by biopsy.
- A biopsy sample is available for tests.
- You’ve had 1–5 previous courses of treatment for mantle cell lymphoma.
- Your lymphoma didn’t respond to your most recent course of treatment or has got worse since your last treatment.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to take part in the trial.
- You are 18 or over.
You will not be able to enter if:
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You are being treated with another investigational drug.
- You’ve been treated with venetoclax, ibrutinib or similar drugs before.
- Your lymphoma is in your central nervous system (CNS; brain spinal and spinal cord) or you have had lymphoma in your CNS in the past.
More information about this trial is available at clinicaltrials.gov.