Purpose of trial
The aim of the trial is to investigate a new drug called tazemetostat (formerly called E7438) and find out:
- the maximum dose that can be given without causing serious side effects
- more about the side effects
- how well it works for follicular lymphoma and diffuse large B-cell lymphoma that have come back (relapsed), or are not responding to treatment (refractory).
Some people with DLBCL also take a steroid, prednisolone, to see if the combination of drugs is safe and effective. .
Tazemetostat is a type of cell signal blocker called an EZH2 histone methyl transferase (HMT) inhibitor. It targets and blocks a protein that encourages lymphoma cells to divide and multiply. Blocking this protein may help to stop lymphoma from growing.
This trial is divided into 2 parts. Only part 2 is still open to recruitment. Part 1 found the highest safe dose of tazemetostat. Part 2 aims to test how well the highest safe dose of tazemetostat works.
Tazemetostat is a drug that you take every day. You have it by mouth (orally), twice a day. You continue to take it for as long as it is helping you.
Some people in this trial take tazemetostat together with the steroid prednisolone. If you are in this group, you take prednisolone tablets on days 1-5 and 15-19 of each 28-day cycle for 4 cycles of treatment. You take tazemetostat every day.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 189 people are needed for this trial.
You may be able to enter if:
- You have diffuse large B cell lymphoma (including primary mediastinal B-cell lymphoma) or follicular lymphoma that has come back or is no longer responding to treatment.
- You have previously had at least 2 courses of treatment for your lymphoma.
- You can’t have an autologous stem cell transplant.
- Your lymphoma is measurable by the tests used in the trial.
- There is some of your lymphoma tissue available from a previous biopsy.
- 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.
- Your blood and other health test results are satisfactory.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You agree not to have Seville oranges or grapefruit (including juice) as these can interfere with the study drug.
- 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.
- Your doctor thinks you still have significant side effects from your previous treatment.
- You have been treated with a similar drug before.
- You can’t swallow tablets or capsules.
- You have a problem with your digestive system that means you might not be able to properly absorb the trial treatment.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have an infection that needs treatment.
- You’ve had surgery in the last 4 weeks.
- You have had any cancer treatment recently. Ask the trial doctor for details.
- You are taking or have taken certain other drugs.
- You are taking certain other drugs that might interfere with the study treatment. Ask the trial doctor for details.
- You have HIV or another condition that affects your immune system.
- You have had an organ transplant.
- You have had another cancer in the last 5 years, except certain localised cancers.
- You are pregnant or breastfeeding.
- The study drug is not suitable for you.
More information about this trial is available at clinicaltrials.gov.