A trial looking at new drugs in combination with cytarabine for acute myeloid leukaemia (AML LI-1)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Leukaemia
Myelodysplastic syndrome (MDS)

Status:

Open

Phase:

Phase 2/3

This trial is looking at new drugs in combination with cytarabine (Ara C) for acute myeloid leukaemia and high risk myelodysplastic syndrome (MDS).

Doctors often treat acute myeloid leukaemia (AML) and high risk MDS with intensive chemotherapy to try and get rid of it. But some people can’t or don’t want to have intensive chemotherapy. For these people doctors may use the chemotherapy drug cytarabine at a lower dose than in intensive chemotherapy. They know cytarabine works but are always looking for new treatments.

In this trial some people will have cytarabine and others will have cytarabine in combination with newer drugs. The researchers will compare the groups to find out which is best for treating people with AML and high risk MDS.

Who can enter

You may be able to enter this trial if you

  • Have acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception if your partner could become pregnant
  • Are 60 years of age or older – some younger patients may be able to take part

You cannot enter this trial if you

If you have another serious heart problem or had a heart attack in the last year, you cannot have AC220, tosedostat or ganetespib but you may still be able to take part in this trial and have one of the other new drugs.

Trial design

This is a phase 2/3 trial. It will recruit 1,000 people.

It is a randomised trial. You are put into a treatment group by a computer. Neither you nor your doctor can choose which group you are in. The groups are:

  • Cytarabine and AC220
  • Sapacitabine
  • Cytarabine (which is the standard treatment)
  • Cytarabine and vosaroxin
  • Vosaroxin
  • Cytarabine and ganetespib
  • Cytarabine and tosedostat
  • Cytarabine and selinexor
  • Cytarabine and lenalidomide

Please note: People are no longer been put into the following treatment groups:

  • Vosaroxin
  • Sapacitabine
  • Cytarabine and vosaroxin
  • Cytarabine and ganetespib

Not all of the treatment groups will be available at every centre, all of the time. Your doctor will tell you which ones are available to you.

The treatments repeat every 4 to 6 weeks, depending on the treatment you are having and how your AML responds to treatment. Each 4 to 6 week period is called a cycle of treatment.

You have cytarabine as an injection under the skin. You have it twice a day for 10 days every 4 to 6 weeks. You may be able to have this at home. You can talk to your doctor about this.

AC220 is a tablet. You take it for the first 3 weeks of each cycle of treatment. You take this at home.

Tosedostat is a capsule which you take every day for 6 months. You take it  at home. 

Selinexor is a tablet which you take in combination with cytarabine. After completing 4 cycles of treatment of selinexor with cytarabine, you can continue taking selinexor once a week.

Lenalidomide is a capsule you take once a day for 3 weeks during every cycle of treatment with cytarabine. After 12 weeks your doctor will talk to you about continuing to take lenalidomide and cytarabine together or taking lenalidomide only. 

You have at least 4 cycles of treatment. You may continue having treatment as long as it is helping you.

You fill in a questionnaire before starting treatment and at 3, 6 and 12 months. It will ask about how you have been and any side effects you have. This is called a quality of life study.

The researchers will also ask your permission to store blood and bone marrow samples. They will take the blood samples when you have your routine samples taken. And the bone marrow samples from when you had your bone marrow test done. These samples will be used in future to find out more about AML. You don’t have to agree to these if you don’t want to. You can still take part in the main trial.

The researchers may also ask for additional blood samples if you are having one of the new drugs. This is to find out more about the how the drug is working.

Hospital visits

You will see the doctor and have some tests before starting treatment. These may include

  • Blood tests
  • Heart trace (ECG)

When you have started your treatment you have blood tests and if taking AC220 a heart trace (ECG).

Side effects

The most common side effects of the drugs used in this trial are

We have more information on cytarabine in our cancer drugs section.

Location

Aberdeen
Airdrie
Aylesbury
Bangor
Belfast
Blackpool
Boston
Bournemouth
Bradford
Bristol
Cambridge
Cardiff
Cheltenham
Chester
Chichester
Colchester
Edinburgh
Exeter
Forth Valley
Glasgow
Gloucestershire
Harrow
High Wycombe
Huddersfield
Hull
Ipswich
Keighley
Kings Lynn
Leicester
Lincoln
Liverpool
London
Manchester
Middlesbrough
Northampton
Nottingham
Oldham
Oxford
Peterborough
Plymouth
Poole
Portsmouth
Prescot
Reading
Rhyl
Romford
Salford
Salisbury
Southampton
Southport
St Leonards-on-sea
Stockton-on-Tees
Surrey
Swansea
Truro
Wakefield
West Bromwich
Wiltshire
Wirral
Yeovil

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

Mike Dennis

Supported by

Bloodwise
Cardiff University
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8642

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

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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