A trial of quizartinib for acute myeloid leukaemia

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

Status:

Closed

This trial is looking at a new drug called quizartinib (AC220) to treat acute myeloid leukaemia. The trial is for people whose acute myeloid leukaemia (AML) continued to get worse during their first treatment or came back within 6 months afterwards.

More about this trial

Doctors treat AML with chemotherapy to get rid of the leukaemia. After chemotherapy you may also have a bone marrow Open a glossary item or stem cell transplant Open a glossary item to stop the leukaemia coming back. Unfortunately sometimes these treatments don’t work. For people in this situation doctors usually try different chemotherapy drugs. The researchers think that quizartinib may help people in this situation.

Quizartinib (pronounced kwiz-art-in-ib) is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

In this trial the researchers want to compare quizartinib with chemotherapy to find out which works best for people whose acute myeloid leukaemia continued to get worse during their first treatment or came back within 6 months.

Who can enter

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

  • You have acute myeloid leukaemia (AML)
  • Your AML came back within 6 months of the first course of treatment you had when you were diagnosed (first line treatment), or continued to get worse during your first course of treatment
  • Your treatment included an anthracycline chemotherapy drug Open a glossary item or another chemotherapy drug called mitoxantrone
  • You have a change to the gene Open a glossary item called FTL3-ITD (your doctor can tell you this)
  • Your doctor thinks you are able to have more chemotherapy
  • You have stopped all other treatment for AML for at least 2 weeks or longer (your doctor can advise you about this)
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • You are willing to use 2 reliable forms of contraception during treatment and for at least 3 months afterwards if you or your partner could become pregnant
  • You are willing for the trial team to tell your GP you are taking part
  • You are at least 18 years old

You cannot join this trial if any of these apply

  • You have acute promyelocytic leukaemia
  • Your leukaemia has (or had) spread to your brain or spinal cord
  • Your leukaemia was caused by chemotherapy for another cancer (apart from myelodysplastic syndrome (MDS) Open a glossary item)
  • Your leukaemia has a change to the gene FLT3-D835. If you have had treatment for FLT3, (apart from midostaurin), there must no longer be any sign of the FLT3-D835 gene change  in your leukaemia cells (your doctor can tell you this)
  • You still have side effects from previous treatment, apart from a drop in blood cells
  • You have moderate or severe graft versus host disease (GVHD) or GVHD that required new treatment in the last 3 weeks
  • You have a problem with the way your blood clots
  • You have already had quizartinib
  • You have had another cancer in the past 5 years apart from some early cancers Open a glossary item that have been successfully treated (the trial team can advise you about this)
  • You have had major surgery in the past month
  • You have had radiotherapy Open a glossary item in the past month
  • You have certain serious heart problems (the trial team can advise about this)
  • You have an infection that isn’t controlled with medication
  • You have HIV, hepatitis B or hepatitis C
  • You are not willing to have a blood transfusion Open a glossary item as part of the trial if necessary
  • You have any other serious medical condition or mental health problem that the trial team thinks could affect you taking part in the trial
  • You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need 326 people to join.

It is a randomised trial. The 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.

  • 2 out of every 3 people will have quizartinib
  • 1 out of every 3 people will have chemotherapy

Quizartinib is a tablet you take once a day in the morning on an empty stomach. You take it at least 1 hour before eating or wait until 2 hours after eating. For the first 15 days you take 1 tablet, after this your doctor may increase your dose.

You can continue taking quizartinib as long as it is helping you and the side effects aren’t too bad.

You cannot eat or drink certain foods while taking quizartinib. Your doctor will tell you more about this.

If you have chemotherapy you will have one of the following. Your doctor will talk to you about which may be the best for you.

  • Low dose cytarabine
  • Mitoxantrone, etoposide and cytarabine (MEC)
  • Fludarabine, idarubicin, cytarabine, and G-CSF (FLAG-IDA)

You can have cytarabine as a drip into a vein or as an injection under the skin.

You can have fludarabine and etoposide as a drip into a vein or as tablets.

You have idarubicin as an injection into a vein.

You have G-CSF as a drip into a vein and as an injection under the skin.

You have chemotherapy every 4 weeks. Each 4 week period is called a cycle of treatment.

If you are having low dose cytarabine you can continue treatment as long as it is helping you and the side effects aren’t too bad. If you are having MEC or FLAG-IDA you can have up to 2 cycles of treatment.

The researchers may use some of your bone marrow and blood samples to find out about changes to your other genes because of your AML.  You have to agree to this to participate in the trial.

The researchers will also ask for extra blood samples and a swab of your mouth during the trial. These extra blood samples and some of your bone marrow may be used in future research to find out more about leukaemia and how to treat it. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These tests include

  • A physical examination
  • Blood tests
  • Chest X-ray
  • Heart trace (ECG Open a glossary item)
  • Heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • Bone marrow test

During treatment you see the doctor regularly for the same tests, apart from the chest X-ray.

At the end of treatment you see the doctor for the same tests, apart from the heart scan and chest X-ray.

After treatment the research team will telephone you every 3 months to see how you are. Your doctor will tell you how often they want to see you.

Side effects

Quizartinib is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include

We have information about the side effects of

Your doctor will talk to you about all the possible side effects before you agree to take part in the trial.

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 Nigel Russell

Supported by

Daiichi Sankyo
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12471

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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