A trial looking at treatment for adults with acute lymphoblastic leukaemia (UKALL14)

Cancer type:

Acute leukaemia
Acute lymphoblastic leukaemia (ALL)
Blood cancers
Leukaemia

Status:

Open

Phase:

Phase 3

This trial is looking at new combinations of treatment for acute lymphoblastic leukaemia (ALL). In particular, it is looking at treatments for adults between 25 and 65 years old who have recently been diagnosed with acute lymphoblastic leukaemia, and for people between 19 and 65 who have ALL with the Philadelphia chromosome.

This trial is supported by Cancer Research UK.

More about this trial

Doctors usually treat acute lymphoblastic leukaemia (ALL), including ALL with the Philadelphia chromosome Open a glossary item, with several different chemotherapy drugs. They often use high doses of chemotherapy, sometimes alongside a stem cell transplant.

In this trial, the research team are looking at changing the treatment in several different ways. They are

  • Giving a biological therapy called rituximab (Mabthera) as well as standard chemotherapy for people with B cell ALL
  • Giving the chemotherapy drug nelarabine (Atriance) as well as standard chemotherapy for people with T cell ALL
  • Using a newer form of the chemotherapy drug asparaginase called pegylated Open a glossary item asparaginase for some of the people taking part in the trial
  • Looking at who benefits most from having a stem cell transplant

The aim of this trial is to see if they can improve treatment for adults with ALL.

Please note - part of the trial also looked at comparing 2 doses of a drug called palifermin to see if it helped stop people having a stem cell transplant getting a sore mouth (mucositis). But from April 2016, this treatment was no longer included in this trial.

Who can enter

You can enter this trial if you

  • Have recently been diagnosed with acute lymphoblastic leukaemia (ALL) and have not yet had any treatment
  • Are between 25 and 65 years old (inclusive) or between 19 and 65 if you have ALL with the Philadelphia chromosome Open a glossary item
  • Are willing to use reliable contraception during the trial and for a year afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have a mature B cell leukaemia such as Burkitt type ALL
  • Are in the blast transformation stage of chronic myeloid leukaemia (CML)
  • Are HIV positive
  • Have hepatitis B or hepatitis C
  • Are pregnant or breastfeeding

Trial design

This is a phase 3 trial and will recruit about 720 people. The trial team estimate that about 4 out of 5 people taking part will have B cell ALL, and 1 out of 5 will have T cell ALL.

Some parts of the trial are randomised. The people taking part will be put into groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Treatment for leukaemia is intensive and will last for several months. It is too complicated to go into detail here, but below is an outline of the trial. Your doctor will be able to tell you more about it.

The first part of treatment for leukaemia is called remission induction. The aim is to destroy the leukaemia cells.

Everyone taking part will have several chemotherapy drugs as part of induction. Those with B cell ALL will be randomised to have rituximab or no rituximab. And those with T cell ALL will be randomised to have nelarabine or no nelarabine.

Treatment after that depends on factors such as how well the induction treatment works, and how old you are when you join the trial. Below, there is a brief summary of treatment for different situations.

If your ALL goes away completely, you have a brother or sister who can donate stem cells, and are 40 or younger, you will have intense chemotherapy followed by a stem cell transplant. Some people also had the growth factor palifermin before their transplant, but this treatment is no longer part of this trial.

If your ALL goes away completely, you have a brother or sister who can donate stem cells, and are over 40, you will have less intense chemotherapy followed by a stem cell transplant.

If tests show that there is a high risk that your ALL will come back, you don’t have a brother or sister to donate stem cells, and you are 40 or less, you will have intensive chemotherapy followed by a stem cell transplant using stem cells from a donor you are not related to (a MUD, or matched unrelated donor transplant). Some people were randomised to have the growth factor palifermin. But they won't be giving this treatment to any more people as part of this trial.

If tests show that there is a high risk that your ALL will come back, you don’t have a brother or sister who can donate stem cells, and you are over 40, you will have less intensive chemotherapy and then a matched unrelated donor (MUD) stem cell transplant.

If tests show that there is a medium risk (or standard risk) that your ALL will come back, you will have chemotherapy in 2 parts. They are called consolidation (to stop the leukaemia coming back) and maintenance (to keep the leukaemia away long term).

Hospital visits

You will see the doctors and have some tests before you join the trial. The tests include

You will see the doctors and have blood and bone marrow tests regularly during and after your treatment. If you have a stem cell transplant you will also have a CT scan.

If you are in the ‘standard risk’ group you will see the doctors every 3 months during maintenance treatment, and then yearly once you finish treatment. If you have a stem cell transplant, you will see the doctors every 3 months for 2 years, and then yearly after that.

Treatment for leukaemia is very intensive and you are likely to be in hospital on and off for several months whether you take part in this trial or have ‘standard’ treatment.

Side effects

The side effects of treatment for acute lymphoblastic leukaemia can be severe. But that is likely to be the case whether you take part in this trial or not.

The chemotherapy drugs used to treat ALL include daunorubicin, vincristine, methotrexate, asparaginase, cyclophosphamide, cytarabine and etoposide. The most common side effects of these drugs are

The most common side effects of rituximab (Mabthera) include

  • Flu like symptoms
  • Low blood pressure
  • Feeling or being sick
  • Diarrhoea
  • Rash

The most common side effects of nelarabine (Atriance) include

  • Weakness, dizziness or extreme tiredness
  • Confusion
  • Loss of balance and coordination
  • Numbness or tingling in fingers and toes (peripheral neuropathy)
  • Blurred vision

The most common side effects of a stem cell transplant are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Sore mouth
  • Infertility
  • Graft versus host disease (GVHD), which means that the donated stem cells attack your own body cells

There is more about side effects of treatment for ALL and you will find more information about side effects of specific drugs if you click on the links above.

Location

Aberdeen
Bangor
Basingstoke
Bath
Belfast
Birmingham
Blackpool
Bournemouth
Bradford
Bristol
Cambridge
Cardiff
Chichester
Coventry
Dewsbury
Dudley
Dundee
Dunfermline
Edinburgh
Exeter
Glasgow
Gloucester
Hull
Ipswich
Kilmarnock
Kirkcaldy
Leeds
Leicester
Liverpool
London
Manchester
Middlesbrough
Newcastle upon Tyne
Northallerton
Northampton
Nottingham
Nuneaton
Oxford
Plymouth
Pontefract
Poole
Portsmouth
Prescot
Rhyl
Sheffield
Southampton
Stoke-on-Trent
Sutton
Swansea
Torquay
Truro
Uxbridge
Wakefield
Warwick
West Bromwich
Wirral
Wishaw
Wolverhampton
Worthing

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 Adele Fielding

Supported by

Cancer Research UK
Cancer Research UK & UCL Cancer Trials Unit
Chugai Pharma UK Ltd
Baxalta
Novartis Pharmaceuticals UK Ltd
NIHR Clinical Research Network: Cancer
Roche
Sigma Tau
Swedish Orphan Biovitrum

Other information

This is Cancer Research UK trial number CRUK/09/006.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

1849

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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