A trial looking at treatment for children and young people with anaplastic large cell lymphoma that has not responded to treatment or has come back (NHL 2006 01)

Please note this trial is no longer recruiting patients.

This trial is looking at chemotherapy and stem cell transplants for children with anaplastic large cell lymphoma (ALCL) that has either not responded to treatment, or has come back (relapsed) after treatment.

This trial is for children and young people up to the age of 21. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

ALCL is a rare type of non Hodgkin’s lymphoma. Children with ALCL usually have treatment with a combination of different chemotherapy drugs. But for a very small number of children, this treatment does not work, or their ALCL comes back later (relapses). This is then difficult to treat with chemotherapy alone.

This international trial aims to find out if

Chemotherapy, followed by a stem cell transplant, will be better at stopping ALCL from coming back in some children
Vinblastine chemotherapy will help children with ALCL that comes back at a later time

Recruitment

Start 01/03/2006

End 15/10/2009

Phase

Phase 3

Who can enter

Your can enter this trial if you

Have anaplastic large cell lymphoma (ALCL) that has not responded to initial treatment OR has come back (relapsed) after initial treatment
Are under 22 years of age

Your cannot enter this trial if you

Have ALCL that has relapsed for a second time
Have any medical condition or illness that means you cannot have the treatment in this trial
Have had another cancer (before you were diagnosed with ALCL)
Have had an organ transplant
Are already taking part in another clinical trial
Are 22 years of age or older

Trial design

This international trial hopes to recruit about 96 children and young people over about 6 years. The treatment plan is quite complex and so it is not possible to describe it in full here. Your doctor will explain your treatment in more detail.

There are 4 different treatment groups. Which group you are in will depend on

When your ALCL came back (relapsed)
Whether a matched donor is available
Whether you have had vinblastine chemotherapy before
Whether your lymphoma cells are CD3 positive or negative

The doctors will have tested some of your lymphoma cells to see if you have a marker on them called CD3. If you have CD3 on your lymphoma cells (CD3 positive) your ALCL is more difficult to treat. So you will have more intensive treatment, including higher doses of chemotherapy.

Group One

If you are in group one, this means that your ALCL relapsed early, during your initial chemotherapy. Your lymphoma may be either CD3 negative or positive.

You have chemotherapy, followed by a stem cell transplant. Your transplant will use someone else’s stem cells (an allogeneic stem cell transplant). The stem cells may be from your brother or sister if they are a good match. If this is not possible, your doctors will try to find a good match from one of the donor registers.

Group Two

If you are in group two, this means that your ALCL relapsed at the end of your initial chemotherapy. You also have CD3 positive lymphoma.

You will have high dose chemotherapy. If the chemotherapy is working, you then have a stem cell transplant using someone else’s stem cells (an allogeneic stem cell transplant). The stem cells may be from your brother or sister if they are a good match. If this is not possible, your doctors will try to find a good match from one of the donor registers.

If you do not have a match, you have another course of chemotherapy. Your then have a transplant using their own stem cells (autologous stem cell transplant).

Group Three

If you are in group three, this means that your ALCL relapsed after your initial chemotherapy finished. You also have CD3 negative lymphoma.

You will have high dose chemotherapy (higher doses than group two). If the chemotherapy is working, you then have a further course of chemotherapy followed by a transplant. You will have a transplant using your own stem cells (autologous stem cell transplant).

Group Four

If you are in group four, this means that your ALCL relapsed over 1 year after your diagnosis. You have CD3 negative lymphoma and you have not had vinblastine chemotherapy before.

Your chances of a cure are still good with chemotherapy alone. You will have vinblastine once a week, every week for about 2 years.

Hospital visits

Before your treatment starts, you will be examined by a doctor and have various tests. These will include

Blood tests
Chest X-ray
Scans, such as CT scan, MRI scan or ultrasound scan
A bone marrow test
A lumbar puncture

Some of these will be repeated during treatment. Most of the children in this trial will be in hospital on and off for some months. The length of time will vary depending on which treatment group you are in.

When your treatment has finished you will be seen regularly by your doctor. You will be examined and you may have blood tests and scans. The frequency of these appointments will depend on the type of treatment you had. You will probably be seen every month for the first 6 months and less frequently after that.

Side effects

The most common side effects of chemotherapy include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
Loss of appetite
Dry and sore mouth
Diarrhoea

Your doctor will be able to tell you which drugs you will have. There is more information about the specific side effects of the drugs on CancerHelp UK. Just click on the drug names.

There is more information about the side effects of a stem cell transplant on CancerHelp UK.