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

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 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)
• 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   this is 6 weeks
• have had a targeted cancer drug in the past 2 weeks, for monoclonal antibodies 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 (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 and in situ carcinoma , 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  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)
• have HIV
• have had an organ transplant
• 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