Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of avelumab for peripheral T cell lymphoma (AVAIL-T)
Cancer type:
Blood cancers
High grade lymphoma
Lymphoma
Non-Hodgkin lymphoma
Status:
Open
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.
Location
Birmingham
Derriford
Glasgow
Leeds
Leicester
Liverpool
London
Manchester
Norwich
Nottingham
Oxford
Southampton
Sutton
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
Prof Simon Wagner
Supported by
Bloodwise
Pfizer
University of Birmingham
Questions about cancer? Contact our information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
15562
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Around 1 in 5 people take part in clinical trials
Last reviewed:
About Cancer generously supported by
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Dangoor Education since 2010.