A study to find out whether a PET-CT scan can help to tell who needs to have rituximab or obinutuzumab after the initial treatment for lymphoma (PETReA)
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This study is for people with follicular lymphoma. Everyone taking part is going to have treatment that reaches their whole body (systemic treatment) for the first time.
Cancer Research UK supports this trial.
More about this trial
Follicular lymphoma is a type of non Hodgkin lymphoma (NHL). Doctors usually put NHL into 2 groups, depending on how likely they are to grow and spread. The 2 groups are low grade and high grade NHL. Follicular lymphoma is a type of low grade NHL.
For follicular lymphoma, you usually have treatment with a combination of cancer drugs. You might have one of the following:
- R-CHOP
- R-CVP
- bendamustine and rituximab (BR)
- bendamustine and obinutuzumab (BG)
- G-CHOP. This is obinutuzumab, cyclophosphamide, doxorubicin, vincristine and prednisolone
- G-CVP. This is obinutuzumab, cyclophosphamide, vincristine and prednisolone
This is called the induction treatment. After the induction treatment, you might have rituximab (R) or obinutuzumab (G) alone. This is the maintenance phase. But having more treatment with rituximab doesn’t help everyone with follicular lymphoma.
Doctors would like to know who needs to have rituximab or obinutuzumab after their initial treatment (induction). In this study, they are looking at whether PET-CT scans can help them to decide who needs to have maintenance rituximab.
A PET-CT scan combines a CT scan and a PET scan to give detailed information about the cancer.
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply:
- you have follicular lymphoma that is grade 1, 2 or 3a
- your lymphoma is in at least 2 groups of lymph nodes (stage 2, 3 or 4)
- you have a high number of lymphoma cells (a high tumour burden) – your doctor can tell you more about this
- you are going to have treatment that reaches your whole body (systemic) for the first time
- you have satisfactory blood tests results
- your kidneys are working well
- are well enough to be up and about for at least half of the day (performance status 0, 1 or 2)
- you are willing to use reliable contraception during treatment if there is any possibility that you or your partner could become pregnant
- are at least 18 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have lymphoma in the brain or the spinal cord
- have had another cancer in the past 5 years apart from successfully treated carcinoma in situ of the cervix, breast and prostate, and non melanoma skin cancer
- have HIV
- have hepatitis B or hepatitis C
- have any other serious medical condition that the trial team think could affect you taking part
- are allergic to rituximab, obinutuzumab or anything they contain
- have had a live vaccine in the past month
- are pregnant or breastfeeding
Trial design
This is a phase 3 trial. Researchers hope that about 1000 people with follicular lymphoma will agree to take part.
Everyone taking part has induction treatment with 1 of the following:
- R-CHOP
- R-CVP
- bendamustine and rituximab (BR)
- obinutuzumab and bendamustine (BG)
- G-CHOP
- G-CVP
This is the same as the standard treatment. Your doctor will tell you which treatment you have and what to expect. You have between 6 and 8 cycles of induction treatment. It takes up to 6 months in total.
At the end of the induction treatment, you have a PET-CT scan. Doctors want to find out how well the treatment worked. The treatment you have next depends on the results of the PET-CT scan.
Negative PET-CT scan
You join this group if your lymphoma went away completely (a complete metabolic response).
This part of the study is randomised. The people taking part are put into 1 of the following groups by a computer.
If you had rituximab during the induction treatment, you are put into 1 of 2 groups:
- rituximab
- no more treatment
If you had obinutuzumab during the induction treatment, you are put into 1 of 2 groups:
- obinutuzumab
- no more treatment
Neither you nor your doctor can choose which group you join.
You have rituximab as a drip into a vein or as an injection under the skin. You have it once, every 2 months. This continues for about 2 years.
You have obinutuzumab as a drip into a vein every 8 weeks. This continues for about 2 years.
Your doctor will monitor you regularly if you don’t have rituximab or obinutuzumab.
Positive PET-CT scan
You join this group if you still have active lymphoma cells. This means that there is a higher risk of your lymphoma coming back (relapse).
This part of the trial is also randomised. The people taking part are put into 1 of 4 groups by a computer:
- rituximab alone
- rituximab and lenalidomide
- obinutuzumab alone
- obinutuzumab and lenalidomide
Neither you nor your doctor can choose which group you join.
You have rituximab every 2 months, for about 2 years.
Lenalidomide comes as tablets that you swallow whole once a day, for 21 days. After this, you have a break of a week. And then start another 21 days of lenalidomide. This continues for about 2 years.
You have obinutuzumab as a drip into a vein every 8 weeks. This continues for about 2 years.
Quality of life questionnaires
Everyone taking part completes a quality of life questionnaire before the start of treatment and at set times during the trial.
The questionnaire asks about how you are feeling and how treatment has affected your quality of life.
Blood tests
You have extra blood tests as part of this study. You have it at the same time you have other tests that are part of your normal treatment.
You do not need to agree to have the extra blood tests if you don’t want to. You can still take part in this study.
Tissue sample
The trial team will ask to use a tissue sample of your cancer. This might be the sample they took to diagnose your cancer (archival tumour sample).
You do not need to agree to give an archival tumour sample if you don’t want to. You can still take part in this study.
Hospital visits
You see a doctor and have some tests before taking part. The tests might include:
- a physical examination
- blood tests
- heart trace (ECG)
- heart scan (ECHO)
- CT scan and PET-CT scan
- a bone marrow test
During treatment, you see the trial team regularly. How often you see them depends on the treatment you have. You have a physical examination and blood tests each time you see them.
You have a CT scan before and after induction treatment, and every year after you finish treatment. You also have a PET-CT scan:
- before the start of induction treatment
- 6 weeks after you finish induction treatment
- a year after the start of maintenance treatment if you have a positive PET-CT scan after the induction treatment
When you finish treatment, you see the trial team every 6 months. This continues for as long as you don’t have any signs of the lymphoma coming back.
You stop this study if your lymphoma comes back. Your doctor can tell you which other treatments you might have.
Side effects
The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the study.
The most common side effects of rituximab are:
- palpitations, breathlessness, feeling faint, sweating, shaking and low blood pressure during the infusion
- redness, tenderness and swelling at the site of the injection
- common infections such as chest and sinus infection
- skin rash
The most common side effects of lenalidomide are:
- a drop in the number of blood cells causing infections, anaemia and bleeding
- blurred vision
- diarrhoea or constipation
- pain in your tummy (abdomen) and mouth
- indigestion and feeling or being sick
- tiredness (fatigue)
- swelling
- infections
The most common side effects of obinutuzumab are:
- infusion reactions such as palpitations, breathlessness, feeling faint, sweating, shaking and low blood pressure
- common infections such as chest and sinus infection
- skin rash
We have more information about the possible side effects of rituximab, lenalidomide and obinutuzumab.
And information about the possible side effects of:
Location
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.
Chief Investigator
Professor Andrew Pettitt
Supported by
Cancer Research UK
National Cancer Research Institute (NCRI)
University of Liverpool
Other information
This is Cancer Research UK trial number CRUK/16/017.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
