A trial of lenalidomide with rituximab for low grade non Hodgkin lymphoma (The AUGMENT trial)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

Low grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 3

This trial is looking at a drug called lenalidomide alongside rituximab for low grade lymphoma that has got worse or come back despite having other treatment.

Certain types of non Hodgkin lymphoma are slow growing. They are called low grade or indolent lymphoma. This trial is for people who have types of low grade lymphoma called follicular lymphoma and marginal zone lymphoma.

Doctors can treat these low grade lymphomas with treatments such as a drug called rituximab, or a combination of chemotherapy and rituximab.

But low grade lymphoma can get worse during treatment, or come back afterwards. If that happens, there are various treatments that doctors can use. In this trial, researchers are looking at a drug called lenalidomide alongside rituximab.

Lenalidomide is called an immunomodulatory agent. It affects how your immune system works.

The aim of the trial is to see how well the combination of rituximab and lenalidomide works, and how safe it is compared to rituximab alone.

Who can enter

You may be able to join this trial if all of the following apply. You

Have a type of low grade lymphoma called marginal zone lymphoma or a follicular lymphoma that is grade 1, 2 or 3A (your doctor can confirm this)
Need to have treatment and the trial doctor thinks rituximab is suitable for you
Have already had one other type of treatment that reached your whole body (systemic treatment ), but your lymphoma got worse during this treatment, or came back afterwards (the treatment may have been rituximab, a combination of chemotherapy and rituximab, or a monoclonal antibody with a radioactive molecule attached, such as Zevalin)
Have lymphoma that can be seen on a scan and at least one area measures more than 1½ cm across
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during the trial and for 4 weeks afterwards if there is any chance you or your partner could become pregnant. Women joining the trial must also use contraception for 4 weeks before starting the trial treatment

As well as the above, if you’ve already had rituximab, your lymphoma must have responded to it and didn’t start getting worse for at least 6 months after the last dose you had.

You cannot join this trial if any of these apply. You

Have lymphoma in your brain or spinal cord
Have follicular lymphoma that is grade 3B
Have any type of lymphoma other than marginal zone lymphoma or follicular lymphoma
Have had major surgery in the last 4 weeks
Have had any other lymphoma treatment that reached your whole body (systemic treatment) in the last 4 weeks
Have had a monoclonal antibody in the last 8 weeks
Have had a drug with a radioactive molecule attached to it in the last 6 months
Have already had lenalidomide
Are known to be allergic to the drug thalidomide
Have damage to the nerves in your hands and feet (peripheral neuropathy) unless this is very mild
Take steroids in the week before starting the trial treatment, unless this is only a low dose (the trial team can advise you about this)
Have active hepatitis B infection
Are known to be hepatitis C or HIV positive
Are known to be very sensitive to products made in a similar way to rituximab
Are at high risk of getting a blood clot and aren’t willing to have medication to prevent this
Have had any other cancer in the last 10 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
Have any other medical condition or mental health problem that the trial team think could affect your taking part
Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The researchers need about 350 people to join.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

People in one group have rituximab and lenalidomide. People in the other group have rituximab and a dummy drug (placebo Open a glossary item ).

AUGMENT trial diagram

You have treatment in 4 week periods called cycles of treatment.

In the 1st cycle of treatment, you have rituximab through a drip into a vein once a week. So you have it 4 times in the first treatment cycle. You then have it just once in each of the next 4 cycles of treatment.

You have lenalidomide (or the dummy drug) as tablets once a day for the first 3 weeks of each treatment cycle.

You only have rituximab in the first 5 cycles of treatment. But as long as you don’t have bad side effects, and your lymphoma doesn’t get worse, you can carry on taking lenalidomide (or dummy tablets) for up to a year.

The trial team will ask you to fill out a questionnaire before you start treatment, every 3 cycles during treatment and 6 months after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Heart trace (ECG )
Blood tests
CT scan or MRI scan

You may also need to have a bone marrow test, a lumbar puncture and a lymph node biopsy.

If you have a type of marginal zone lymphoma called MALT lymphoma that started in your stomach, you will need to have an endoscopy (if you haven’t had one in the last 3 months). This is a test using a flexible tube with a camera attached. The doctor puts the tube down your throat and uses it to look at the inside of your stomach. During the test, the doctor can take samples of tissue (biopsies Open a glossary item ).

If your lymphoma responds well to the trial treatment, you will have more endoscopies, so that the trial team can get more samples of your lymphoma to study.

Everybody taking part sees the trial team and has blood tests at least every 4 weeks during treatment. You have a CT or MRI scan every 3 months for 3 years, every 4 months in the following year, every 6 months in the following year and once a year after that.

When you finish treatment, the trial team will continue to check how you are every 6 months for at least 5 years. Depending on your indiviudal situation, this may be at hospital visits, or by phone.

Side effects

The most common side effects of lenalidomide include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Blurred vision
Diarrhoea or constipation
Pain such as tummy (abdominal) pain, aching muscles or joints, chest pain, back pain, bone pain or toothache
Indigestion
Feeling or being sick
Feeing weak and unwell
Tiredness (fatigue)
Swelling in your arms or legs due to a fluid build up
High temperature (fever) and chills
Infection in your lungs (pneumonia) and other types of infections
Sore throat
A stuffy or runny nose
Weight loss
Reduced appetite
High levels of sugar and other chemical imbalances in your blood
Muscle cramps
Dizziness
Taste changes
Headache
Pain or numbness and tingling in your hands and feet (peripheral neuropathy)
Shaking (tremor)
Cough or shortness of breath
Nosebleeds
Blood clots
Changes to your skin such as dry skin, itching or rash
Depression
Problems sleeping

The most common side effects of rituximab include

Infections such as pneumonia
A drop in blood cells causing an increased risk of infection and bleeding problems
Allergic reactions
Feeling sick
Skin rash or itching
High temperature (fever) and chills
Weakness
Headache

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