A trial of tazemetostat for diffuse large B cell lymphoma and follicular lymphoma

Cancer type:

Blood cancers
High grade lymphoma
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 1/2

This trial is for people with diffuse large B cell lymphoma or follicular lymphoma that has come back after or continued to get worse during treatment.

The trial is now only open to people with follicular lymphoma. There are enough people with diffuse large B cell lymphoma taking part in the trial.

More about this trial

Doctors can treat diffuse large B cell lymphoma (DLBCL) and follicular lymphoma with chemotherapy, targeted cancer drug and a steroid such as prednisolone. If your lymphoma comes back, you might have the same treatment.

Tazemetostat is a targeted cancer drug. It blocks an enzyme Open a glossary item that lymphoma cells need to grow and multiply. We know from laboratory studies Open a glossary item that tazemetostat could stop cancer cells from growing and maybe even kill them.

The researchers want to find out if it can help people with lymphoma. In this trial some people with DLBCL will have:

People with follicular lymphoma will have tazemetostat only.

The main aims of this trial are to find out:

  • how well tazemetostat works
  • what the side effects are

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join this trial if all of the following apply. You:

  • have diffuse large B cell lymphoma (DLBCL) or follicular lymphoma that has come back after treatment or continued to get worse during treatment
  • have had at least 2 previous standard treatments Open a glossary item for your lymphoma
  • have an area of lymphoma that can be measured
  • have satisfactory blood test results
  • are able to do anything apart from heavy physical work (performance status 0, 1 or 2)
  • are willing to use reliable contraception during treatment and for a month after if there is any chance you or your partner could become pregnant
  • are at least 18 years old

Who can’t take part
You cannot join this trial if any of these apply.

Cancer related
You:

  • have DLBCL and you are able to have high dose treatment followed by a stem cell transplant using your own cells (autologous stem cell transplant) Open a glossary item
  • have lymphoma spread to the brain or have had treatment for lymphoma spread to the brain  
  • have had chemotherapy in the past 3 weeks, or for a group of chemotherapy drugs called nitrosoureas Open a glossary item  this is 6 weeks
  • have had a targeted cancer drug in the past 2 weeks, for monoclonal antibodies Open a glossary item this is 4 weeks
  • have had radiotherapy in the past 2 weeks to 12 weeks depending on the type of radiotherapy, the trial team can tell you about this
  • have had high dose treatment followed by a stem cell or bone marrow transplant of your own cells (autologous transplant) in the past 2 months
  • have had high dose treatment followed by a stem cell or bone marrow transplant from a donor (allogenic transplant) in the past 3 months
  • have ongoing moderate to severe graft v host disease Open a glossary item (GVDH) following your donor transplant
  • have any ongoing moderate to severe side effects from any previous treatment
  • have already had tazemetostat or a drug that works in a similar way
  • have had another cancer apart from successfully treated non melanoma skin cancer Open a glossary item and in situ carcinoma Open a glossary item, or any previous cancer that was successfully treated and there hasn’t been a sign of it for the past 5 years

Medical conditions
You:

  • are taking medication that affects the CYP enzymes
  • aren’t willing to exclude food from your diet that affects the CYP enzymes
  • have had major surgery in the past 4 weeks, or minor surgery in the last 3 weeks
  • have a problem absorbing medication in your digestive system Open a glossary item or have ongoing problems such as being sick or diarrhoea that can affect how well you absorb medication
  • have had a stroke in the past 6 months
  • have a heart attack, unstable angina or another heat problem in the past 6 months
  • have had a blood clot (DVT) or a blood clot on the lung (PE) in the 3 months before starting treatment
  • have an infection that needs treatment that reaches the whole body (systemic treatment) Open a glossary item
  • have HIV
  • have had an organ transplant Open a glossary item
  • have any other medical or mental health condition that your doctor or the trial team think could affect you taking part

Other
You:

  • are allergic to tazemetostat, prednisolone or any of their ingredients
  • are pregnant or breastfeeding

Trial design

Please note the trial team is no longer asking people with diffuse large B cell lymphoma to join the trial.

There are 2 parts to this trial.

The first part was a phase 1 trial to find the best dose of tazemetostat to give. This part is now closed.

The second part is a phase 2 trial. The trial team need 340 people to take part. There are 6 groups in this part. Some groups are now closed.

Tazemetostat is a tablet you take twice a day. You continue to take tazemetostat as long as it is helping and the side effects aren’t too bad.

You shouldn’t eat grapefruit or drink grapefruit juice for a week before starting tazemetostat. This is because they can affect how much tazemetostat is in your blood.

Prednisolone is a tablet. If you are in one of the groups taking prednisolone your doctor will tell you how many to take and how often.

Tissue and blood samples
The team will ask your permission to get a small sample of tissue from when you were first diagnosed.

When you agree to take part in the trial they will also ask for a sample of tissue (biopsy) taken from your lymphoma and, or a bone marrow sample Open a glossary item. You don’t have to agree to have these done. You can still take part in the trial.

Researchers will use these samples to find out more about lymphoma and what happens to tazemetostat in the body.

When you first start treatment, you have a blood sample taken on 3 separate occasions. They will use these samples to find out what happens to tazemetostat in the body.

Hospital visits

You see the doctor before taking part to have some tests. These include:

For the first 8 weeks of treatment, you will see the doctor every 2 weeks for:

  • a physical examination
  • heart trace
  • blood tests

Then you see the doctor every 4 weeks for the same tests as above. Every 2 weeks a member of the team will phone you to see how you are.

You have the same scans you had a the beginning every 2 months for the first 6 months. Then every 3 months after that.

When you stop treatment, you see the doctor for:

  • a physical examination
  • heart trace
  • blood tests

After treatment a member of the trial team will phone you to see how you are and to ask if you have started any other treatment for your lymphoma.

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:

  • you have severe side effects
  • your side effects aren’t getting any better
  • your side effects are getting worse
  • you notice anything unusual or anything that has changed

Tazemetostat is a new drug and there might be side effects we don’t know about yet. The common side effects of tazemetostat we do know about from ongoing clinical trials include:

We have information about the side effects of prednisolone.

Your doctor or a member of the trial team will tell you about the side effects of tazemetostat and prednisolone before you agree to take part in the trial.

Location

Glasgow
London
Manchester
Southampton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Peter Johnson

Supported by

Epizyme, Inc.
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13512

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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