A trial looking at treatment for acute myeloid leukaemia (AML 17)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

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

Status:

Closed

Phase:

Phase 3

This trial is looking at the treatment for acute myeloid leukaemia (AML) and high risk myelodysplastic syndrome Open a glossary item. This trial is supported by Cancer Research UK.

There are different parts to this trial that are looking at other types of adult acute myeloid leukaemia (AML) and AML in children. There is information about the other parts of the trial listed separately.

This part of the trial is particularly focusing on those who are under 60 years old, although some people over 60 years old may take part.

Doctors use chemotherapy to treat AML. But chemotherapy by itself may not be enough to get rid of AML. Biological therapies may also work with chemotherapy to treat AML.

To stop AML coming back doctors may use more chemotherapy. And, if appropriate, they may suggest a bone marrow or stem cell transplant.

Before having the bone marrow or stem cell transplant, you may have more chemotherapy.

The aims of this trial are to

  • Find out the best dose of daunorubicin
  • Look at CEP-701 to treat AML
  • Look at everolimus to treat AML
  • Compare 2 chemotherapy treatments before a bone marrow transplant
  • Compare 1 with 2 more cycles of chemotherapy to stop AML coming back

Who can enter

You can enter this trial if you

  • Have acute myeloid Leukaemia (AML)
  • Are suitable for intensive chemotherapy
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
  • Are under 60 years of age (older patients can take part if your doctor thinks you are suitable for intensive chemotherapy)

You cannot enter this trial if you

Trial design

This is a national trial that aims to recruit 2,800 patients with AML and high risk MDS in the UK.

This trial has 3 parts. The first part is to get rid of the leukaemia (induction phase). The second part is to stop the leukaemia coming back (consolidation phase). The third part is to find out if it is best to have regular tests after chemotherapy.

At the start of the induction phase you will have daunorubicin.

After the first cycle of chemotherapy, you will have a bone marrow test. This will give the doctor more information about your leukaemia and how it has responded to treatment so far. The doctor will discuss this with you and plan the rest of your treatment. You will be put into 1 of 4 groups.

Group 1
People in this group continue on to have daunorubicin unless their bone marrow shows they have an abnormal chromosome called 'core binding factor' then they have 1 dose of Mylotarg as well.  Mylotarg is a monoclonal antibody.

The people in groups 2, 3 and 4 are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This is called randomisation.

Group 2
In this group the leukaemia cells make too much of the chemical tyrosine kinase. So people in this group were randomised to have CEP-701 or a dummy treatment (placebo) for 4 doses.

If you are in this group and your leukaemia comes back you have another tyrosine kinase called pacritinib.

Group 3
People in this group were randomised to have everolimus or not.

Group 4
In this group, the results of the bone marrow show that there is a high chance your leukaemia may come back after treatment. And the doctor will plan for a bone marrow or stem cell transplant. If you are under 40 years old your doctor may also plan for a bone marrow or stem cell transplant.  If you have chemotherapy before your transplant you will be randomised to have one of the following

You have a bone marrow test after cycle 2 of chemotherapy in groups 1, 2 and 3. If you are in complete remission Open a glossary item, then you will go on to have consolidation chemotherapy.

In the consolidation phase everyone will have high dose Ara-C, but you will be randomised to have 1 or 2 cycles of treatment.

In the third part some people will have regular tests after their chemotherapy and some people will not.

If you take part in this trial, the researchers will ask your permission to store some of your blood and bone marrow samples. These samples will be stored safely and may be used in the future, but for research purposes only. This is because studying these samples may help researchers learn more about leukaemia.

If you don’t wish to have your blood and bone marrow samples stored for research, you don’t have to. You can still take part in the trial.

Hospital visits

Before you start treatment you will see the doctor and have various tests. These tests will include

You will have a blood test and possibly a bone marrow test before each cycle of chemotherapy.

All the chemotherapy is given through a drip into a vein; you will probably have these as an outpatient. There is a possibility that some people may need to have their chemotherapy as an inpatient, so may stay overnight in hospital.

Side effects

All chemotherapy has side effects. The most common side effects for the chemotherapy used in this trail are

Etoposide can cause a metallic taste in the mouth.

Amsacrine and daunorubicin can turn your urine pink or red. This can start up to 2 hours after having them and can last for up to 2 days.

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 A K Burnett
Professor N H Russell

Supported by

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

Other information

This is Cancer Research UK trial number CRUK/08/025.

Contact our cancer information nurses for other questions about cancer by:

Phone - 0808 800 4040

Last review date

CRUK internal database number:

Oracle 12498

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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