A trial of CD19CAR T-cells to treat blood cancers in children and young people (CARPALL)

Cancer type:

Acute leukaemia
Acute lymphoblastic leukaemia (ALL)
Acute myeloid leukaemia (AML)
Children's cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Chronic myeloid leukaemia (CML)
Hairy cell leukaemia
High grade lymphoma
Hodgkin lymphoma
Leukaemia
Low grade lymphoma
Lymphoma
Myeloma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 1

This trial is for children and young people with a leukaemia or lymphoma that has come back or is likely to come back after treatment. 

Children and young people with a leukaemia or lymphoma that has the CD19 protein can take part.  

It is for children and young people up to the age of 24. We use the term ‘you’ in this summary, if you are a parent we are referring to your child.

More about this trial

Chemotherapy can help many children and young people who have leukaemia or lymphoma. But for some their cancer comes back after treatment (relapse). 

Treatment when this happens is usually further chemotherapy or a bone marrow transplant. But this doesn’t always work and researchers are looking at new ways to treat these children and young people.

In this trial researchers are using cells from your immune system called T cells. These cells are very good at helping us fight infections but they aren’t so good at telling the difference between a normal cell and a cancer cell. 

Some blood cancer cells have a protein called CD19 on their surface. 

So, the researchers want to collect your T cells and make a change to them in the laboratory so that they can recognise the CD19 protein. These altered T cells are called CD19CAR T-cells. This treatment is called adoptive cell transfer

You have the CD19CAR T-cells as a drip into a vein (intravenous infusion) Open a glossary item. In your body they attack and kill cells that have the CD19 protein. 

The aims of this trial are to find:

  • if it is possible and safe to give CD19CAR T-cells to children and young people with a blood cancer that has come back 
  • how well CD19CAR T-cells work for these people
  • how long CD19CAR T-cells stay in the body

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 a blood cancer that has the CD19 protein 
  • your cancer is at a high risk of coming back, or your cancer has come back, after treatment 
  • you are able to have your white blood cells collected (harvested)
  • if you are 10 years or older and you need help to care for yourself (Karnofsky performance score of 50 or more), if you are under 10 years old and you take part in quiet play and activities (Lansky performance score of 50 or more)
  • your blood results are satisfactory
  • you have more than 90% oxygen in your blood (oxygen saturation), your doctor will test for this
  • if you are sexually active you are willing to use reliable contraception during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
  • you are 24 years old or younger

Who can’t take part

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

  • have a blood cancer that doesn’t have the CD19 protein 
  • have had a donor bone marrow transplant or donor stem cell transplant (allogeneic transplant) and have GVHD that is causing severe symptoms or you have ongoing (chronic) GVHD that is causing moderate or severe symptoms and you are taking steroids to control them
  • have an infection when you are due to have your CD19CAR T-cells 
  • are having oxygen when you are due to have your CD19CAR T-cells
  • have developed breathing problems by the time you are due to have your CD19CAR T-cells
  • have active HIV, hepatitis B or hepatitis C
  • have a problem with your brain or spinal cord unless it is caused by your blood cancer
  • are pregnant or breastfeeding

Trial design

This is a phase 1 trial. The researchers needs up to 32 people to take part. 

You will have CD19CAR T-cells if you meet the conditions of the trial and the cells can be produced. 

CD19CAR T-cells are made in the laboratory using a particular type of white blood cell called T cells. These are your own T cells that they collect (remove) from your blood during a process called leucapheresis. 

They take the blood from your vein and put it through a machine. The machine separates the T cells from the blood. They remove the T cells and give the rest of your blood back into your bloodstream. It takes about 15 days for them to make the CAR T-cells. 

You go in to hospital to have low dose chemotherapy. The chemotherapy helps your CD19CAR T-cells survive and grow in your body. 

The chemotherapy drugs you have are cyclophosphamide and fludarabine. You have both drugs as a drip into your bloodstream. You have:

  • fludarabine for 5 days – you start this 7 days before you have the altered T-cells
  • cyclophosphamide for 3 days – you start this 4 days before you have the altered T-cells 

The fludarabine drip takes about 30 minutes. The cyclophosphamide takes about an hour. You also have fluids in a drip for 4 hours before you have the cyclophosphamide and for 24 hours after. 

You have one day with no treatment. Then you have your CD19CAR T-cells as a drip into your bloodstream.

CARPALL trial diagram

The drip of CD19CAR T-cells takes 5 to 10 minutes. During this time and for 4 hours afterwards the staff watch you closely. Every 30 minutes the nurse will check your:

  • temperature
  • blood pressure
  • pulse
  • breathing rate
  • level of oxygen in your blood

You stay in hospital for at least 2 weeks after your treatment. 

Sometimes they can't make the CD19CAR T-cells because of technical problems in the lab or because there weren’t enough white blood cells. Your doctor will talk to you about what other treatments are available if this happens.

Hospital visits

You see the doctor to have some tests before taking part. These tests include:

Before having your CD19CAR T-cells you have the following tests:

  • physical examination
  • blood tests
  • oxygen level in your blood
  • bone marrow test

This is to make sure you are well enough to have the CD19CAR T-cells.

After leaving the hospital you see the doctor in the outpatient’s clinic every:

  • month for 6 months
  • 6 weeks to a year after treatment
  • 3 months for another year

During these visits you have the following tests:

  • physical examination
  • blood tests
  • bone marrow test 

People with lymphoma have a CT scan at:

  • a month
  • a year
  • 2 years

You have it if your doctor thinks it would help them find out how well the treatment has worked or your doctor thinks it is suitable. 

People whose cancer has come back in the brain or spinal cord have a lumbar puncture at:

  • a month
  • a year
  • 2 years 

You have it if your doctor thinks it would help them find out how well the treatment has worked. 

After this you see the doctor every year to 10 years.

Side effects

Leucapheresis is a safe procedure and most people don’t have side effects. Side effects might include:

  • feeling lightheaded
  • a drop in the level of calcium in your blood causing numbness and tingling particularly in the hands, feet and around the mouth. It can also cause muscle spams

Your doctor will treat the drop in calcium if it happens. 

This study is the first time this type of CD19CAR T-cells has been used in people. So, there might be side effects we don’t know about yet. 

A possible side effect is an allergic reaction. Signs of an allergic reaction include: 

  • high temperature (fever)
  • shivering
  • difficulty breathing
  • low blood pressure 
  • rash
  • being sick

Another possible side effect is called cytokine release syndrome (CRS). CD19CAR T-cells can cause the release of a chemical in the body called cytokines. The side effects of the release of these cytokines can be mild to severe. They can include:

  • high temperature
  • aching muscles
  • low blood pressure 
  • difficulty breathing

Other possible side effects can include:

  • confusion
  • difficulty speaking
  • difficulty writing
  • decreased alertness
  • fits
  • an increased risk of infection due to a decrease in the number of B cells in your blood
  • an increased risk of developing another cancer

You must contact the study team at the hospital if at any time after having CD19CAR T-cells if you develop:

  • a high temperature (fever)
  • difficulty breathing 
  • light headedness
  • confusion
  • difficulty speaking
  • any unusual symptom

The team will give you card with their contact details. 

We have information about:

Location

London
Manchester

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

Professor Persis Amrolia

Supported by

University College London (UCL)
Children with Cancer UK
Great Ormond Street Hospital Children’s Charity
JP Moulton Charitable Foundation

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14118

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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