A trial of avelumab for peripheral T cell lymphoma (AVAIL-T)

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

Cancer type:

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called avelumab for peripheral T cell lymphoma that has come back or treatment has stopped working.

More about this trial

Peripheral T cell lymphoma (PTCL) is a type of non Hodgkin lymphoma (NHL) that affects blood cells called T cells.

Doctors often use chemotherapy to treat PTCL, but sometimes it continues to grow, or comes back after treatment. Researchers are looking for ways to improve treatment. In this trial, they are looking at a drug called avelumab.

Avelumab is a type of immunotherapy drug called a monoclonal antibody. It works by stimulating the body’s immune system to recognise and kill cancer cells.

The aims of the trial are to find out:

how well treatment works
how safe it is
more about the side effects

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 peripheral T cell lymphoma that has come back or got worse despite after at least 1 treatment
have lymphoma that can be measured on a scan
have satisfactory blood test results
are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
are willing to use 2 forms of reliable contraception during treatment and for at least 60 days after having avelumab
are at least 16 years old

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

You:

have lymphoma in the brain or spinal cord
have side effects from past treatments that haven’t gone away apart from hair loss or moderate numbness and tingling in your hands or feet (peripheral neuropathy)

Medical conditions

You:

have problems with your heart, such as a heart attack in the last 6 months, angina that is not well controlled, you take medication for an abnormal rhythm of your heart or you have fluid around your heart
have had a stroke in the last 6 months
have an active autoimmune disease unless it is vitiligo, type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need treatment
have had a stem cell transplant with somebody else’s cells or an organ transplant such as a liver or kidney transplant
are having medication that dampens down the immune system such as steroids apart from nose drops, skin creams or steroid injections into a joint
have an active infection that needs treatment
have had major surgery within 4 weeks of joining the trial
have lung conditions called pneumonitis or pulmonary fibrosis
have a condition of the bowel called colitis or inflammatory bowel disease
have HIV
have an active hepatitis B or hepatitis C infection
have any other medical problem or mental health problem that the trial team think would affect you taking part

Other

You:

are allergic or sensitive to avelumab or its ingredients or you have had a severe reaction to other types of monoclonal antibodies in the past
have had a live vaccination within 4 weeks of starting trial treatment or you plan to have a live vaccine while having treatment (the flu vaccine is permitted)
have a problem with drugs or alcohol
are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It is taking place in the UK. The researchers need 35 people to join.

Everyone taking part has avelumab. You have it as a drip into a vein. It takes about 60 minutes each time. You have treatment in cycles. Each 4 week period is a cycle of treatment.

The first day of each treatment cycle is called day 1. In each cycle you have:

avelumab on day 1
avelumab on day 15
no treatment until the next cycle starts 13 days later

You’ll stay in the hospital outpatient department for about 2 hours after each treatment. This is to check that you don’t have an allergic reaction to it.

You have treatment for 8 months. You might continue treatment for longer if it is working and the side effects aren’t too bad. Your doctor can tell you more about this.

Samples for research

You give some extra blood samples during treatment. You give the extra samples when you have your routine blood tests if possible. The researchers plan to use the samples to:

see how well the treatment is working
look for biomarkers to predict who will benefit from treatment

The doctors will ask permission to collect an extra tissue sample if your lymphoma gets worse. You do not have to agree to give this sample if you don’t want to. You can still take part in the trial.

They’ll ask to keep any leftover samples for future research.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

physical examination
blood samples
urine samples
heart trace (ECG)
CT scan

You might have a bone marrow test or give a tissue sample if you haven’t had one done in the last 3 months.

You have treatment in the hospital outpatient department. You shouldn’t need to stay overnight.

At each visit you have some blood tests. You see a doctor for a check up once a month.

You have a CT scan at:

3 months
6 months
8 months
and then every 4 months if your lymphoma hasn’t got worse

Follow up

When you stop treatment, you see the trial team for a check up every 4 months for up to 20 months.

Side effects

As avelumab is a new drug for peripheral T cell lymphoma, there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.

The most common side effects of avelumab are:

tiredness (fatigue)
a drop in the number of red blood cells causing an increased risk of tiredness or breathlessness (anaemia)
feeling or being sick
diarrhoea or constipation
fever (high temperatures)
loss of appetite
muscle, joint or bone pain
flu-like illness such as fever, sweats, a cough or sore throat
swelling of the feet or lower legs due to fluid retention

You might have an allergic reaction to avelumab. This might cause:

dizziness
light headedness
chills
shortness of breath
swelling of the face, tongue or throat

Tell your doctor of nurse if you notice any of these symptoms during or within a few hours of having treatment. They’ll keep a close eye on you and treat any symptoms straight away. You’ll have medication before treatment to help stop you having a reaction.

The trial doctor will explain all the possible side effects before you join the trial.