A study looking at treatment for children and young people with ALL that has come back (IntReALL SR 2010)

Cancer type:

Acute leukaemia
Acute lymphoblastic leukaemia (ALL)
Blood cancers
Children's cancers
Leukaemia

Status:

Open

Phase:

Phase 3

This trial is for children and young people up to the age of 18 who have acute lymphoblastic leukaemia (ALL) that has come back after treatment. They must also be in a group called a ‘standard risk’ group. 

Doctors use different risk groups according to: 

  • how quickly the leukaemia came back
  • where the leukaemia came back (for example in the bone marrow Open a glossary item or central nervous system Open a glossary item)
  • whether you have B-cell ALL or a T-cell ALL

Knowing the risk group helps doctors to choose the best treatment. If you don’t know your risk group ask your doctor. They will be able to tell you. 

We use the term 'you' in this summary, but if you are a parent, we are referring to your child. 

More about this trial

The treatment for children and young people with ALL is usually successful. But sometimes it can come back (relapse). In this situation you are given more chemotherapy to treat the leukaemia. You may go on to have a bone marrow transplant. This depends on how many leukaemia cells are left in the bone marrow (this is called minimal residual disease or MRD).

In this study doctors want to compare the chemotherapy usually given for relapsed ALL in the UK with the chemotherapy usually given in Europe. 

The treatment given in the UK is called ALL R3. The European treatment is called ALL-REZ BFM 2002. Both treatments have shown to be useful for people who have relapsed ALL. In this study they want to see if one is better than the other. 

They also want to see if adding a new drug called epratuzumab alongside the chemotherapy improves treatment. Epratuzumab is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

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

  • You have B-cell or T-cell ALL that has come back after treatment (relapsed)
  • You are in the standard risk group
  • If you are sexually active you must be willing to use reliable contraception during the study and for 2 years after you have finished treatment if there is any chance you or your partner could become pregnant
  • You are under 18 years old

You cannot join this study if any of these apply. 

  • Your ALL is Philadelphia chromosome Open a glossary item positive
  • Your ALL has come back after you have had a stem cell transplant using stem cells from a donor (an allogeneic transplant) 
  • You took part in another clinical trial in the month before joining this trial unless this was a trial for your ALL
  • You have another serious medical condition or mental health problem that the study team think could affect you taking part
  • You are pregnant or breastfeeding

Trial design

 This is an international phase 3 trial. Doctors need 306 children and young people worldwide to take part. 

It is a randomised trial. The children and young 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.  

The groups are: 

  • ALL R3 with or without epratuzumab
  • ALL-BFM REZ 2002 with or without epratuzumab

Diagram showing IntReALL SR 2010 Randomisation

The way you have ALL R3 and ALL-BFM REZ 2002 is similar. They just use slightly different chemotherapy drugs. 

You might have all or some of the following drugs:

  • dexamethasone
  • prednisolone
  • vincristine
  • methotrexate
  • cytarabine
  • asaparginase
  • mitoxantrone
  • idarubicin
  • mercaptopurine
  • cyclophosphamide
  • thioguanine

Some of these drugs are tablets, some are given into your central line. And some are injected into the fluid around your spinal cord (an intrathecal injection Open a glossary item).

You have both ALL-R3 and ALL-BFM-REZ-2002 over a period of weeks called ‘blocks’. These include: 

  • an induction block 
  • 2 consolidation blocks
  • 2 more consolidation blocks (also called interim maintenance) 
  • maintenance chemotherapy

If you are in a group having epratuzumab you have it once a week for 8 weeks during the first consolidation block. You have this as a drip into your central line. 

You may need to have a bone marrow transplant. This will depend on how many leukaemia cells are in your bone marrow after you have completed the induction block

Your doctor will talk with you about having a transplant if you need one. 

Blood and bone marrow samples
The doctors will ask if they can take a few more millilitres (a few teaspoons) of bone marrow when you have a routine bone marrow test.They want to use these samples to see if they can learn more about why ALL comes back in some people. They also want to see if they can find better ways to treat ALL. 

The samples may also be used for future research looking at treatment, diagnosis and the genetics of children’s cancers. 

If you are in a group having epratuzumab you may need to have a small amount of extra blood taken at the same time as your routine blood tests. This is so the doctors can check the level of epratuzumab in your blood. 

Hospital visits

You will be in hospital for most of your treatment. You should be able to go home between treatments if you are well enough. But you will need to go to the hospital at least once a week so the doctors can see how you are. 

The study team will give you information about what you can expect if you take part in the study. 

Side effects

The most common side effects of the chemotherapy drugs used in this study include: 

The main side effects of epratuzumab are mild reactions such as a high temperature (fever) and flu like symptoms when you have the drug.  

We have information on: 

Location

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

Dr Denise Bonney

Supported by

Central Manchester University Hospitals NHS Foundation Trust
Charité - Universitätsmedizin Berlin
EU Seventh Framework Programme (FP7)
NIHR Clinical Research Network: Cancer
University of Manchester

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13515

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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