A trial of clofarabine and liposomal daunorubicin for children and teenagers with acute myeloid leukaemia (CLOUD)

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

Children's cancers

Leukaemia

Status:

Closed

Phase:

Phase 1

This trial is looking at clofarabine and liposomal daunorubicin for children and young people who have acute myeloid leukaemia (AML).

This trial is for children and teenagers up to the age of 18. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.

Doctors often treat AML with chemotherapy. This usually works very well. But if AML stops responding to treatment, or comes back (relapses) it can be more difficult to treat. Doctors are looking for new combinations of drugs to treat AML that no longer responds to standard treatment Open a glossary item .

Clofarabine is a chemotherapy drug that doctors already use to treat children with acute lymphoblastic leukaemia. In this trial, researchers want to see if a combination of clofarabine and another drug called liposomal daunorubicin can help children and young people who have AML.

Liposomal daunorubicin is already sometimes used to treat children with AML. Liposomal drugs are “wrapped up” in a fatty covering called liposome. This helps the drug to work better and causes less severe side effects.

The aims of the trial are to

Find the highest dose of clofarabine that you can safely have at the same time as liposomal daunorubicin
Learn more about the side effects
See if this combination of drugs helps children and teenagers with AML that is not responding to standard chemotherapy

Who can enter

You can enter this trial if you

Have been diagnosed with AML that is not responding to induction chemotherapy and more than 20% of your bone marrow is made up of undeveloped blood cells (blasts) or
Have AML that has come back within 1 year, or has come back more than once and more than 5% of your bone marrow is made up of blasts
Are at least 6 months old, but have not yet reached your 18th birthday
Are well enough to take part in the trial - this means you have a Karnofsky score of at least 50, or if your child is under 16, the trial team will use another scale to measure how much they can play and how much they need to rest
Have satisfactory blood test results
Have recovered from the side effects of any other treatment
Are willing to use reliable contraception during the trial if there is any chance you could become pregnant

You cannot enter this trial if you

Have AML that has come back more than a year after you were first diagnosed
Have only one area of AML that is outside your bone marrow (isolated extramedullary leukaemia)
Have AML that has spread to your brain or spinal cord (the central nervous system) and is causing symptoms
Have had a stem cell transplant in the last 6 months
Have any signs of a side effect called graft versus host disease after a transplant
Have not recovered from other side effects of a transplant
Have already had a large dose of daunorubicin or a similar drug (the trial doctors can advise you about this)
Have had chemotherapy in the last 2 weeks
Have had monoclonal antibody treatment in the last 2 weeks
Are having any other treatment for AML, or any other experimental drug as part of another clinical trial
Have certain heart problems (the trial doctors can advise you about this)
Have an infection or any other serious medical condition

Trial design

This is a phase 1 trial. It will recruit between 12 and 18 people. Everybody taking part will have clofarabine and liposomal daunorubicin. The first patients taking part will have the lowest dose of clofarabine. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a ‘dose escalation study’. Everybody will have the same dose of liposomal daunorubicin.

You have clofarabine every day for 5 days through a drip into a vein. You will probably have this via a central line or portacath. It takes 2 hours each time. On days 1, 3 and 5, you also have liposomal daunorubicin through the drip. This starts about 4 hours after the clofarabine and also takes about 2 hours.

If the trial treatment helps you, the doctors may talk to you about having other treatments such as a bone marrow transplant.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Bone marrow test
Heart trace (ECG )
Heart scan (echocardiogram )
Pregnancy test (if you are female and could possibly become pregnant)

You will be in hospital for at least 5 days to have this treatment. You have more blood tests at the end of the first week and then each week for the next month. You have another ECG and echocardiogram between 3 and 4 weeks after starting treatment, and another bone marrow test between 3 and 6 weeks after starting. You see the trial doctors at the end of 6 weeks and then once a month after that. You will have blood tests each time.

Side effects

As this is a new combination of drugs, there may be some side effects that we don’t know about yet. The side effects of liposomal daunorubicin and clofarabine that are known include

A drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Sickness
Diarrhoea
Sore mouth
Hair loss
Headache
Tiredness (fatigue)
Weakness
Shivering
Breathlessness
Changes to the heart

There is more information about the side effects of chemotherapy on this website.

Recruitment start:

01/06/2009

Recruitment end:

01/06/2011

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Professor Pamela Kearns

Supported by

Bloodwise
Cancer Research UK Clinical Trials Unit University of Birmingham
Children's Cancer and Leukaemia Group (CCLG)
Experimental Cancer Medicine Centre (ECMC)
Genzyme Co
NIHR Clinical Research Network: Cancer

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