A trial of oral azacitidine for acute myeloid leukaemia that has completely disappeared after chemotherapy (QUAZAR AML-001)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Leukaemia

Status:

Results

Phase:

Phase 3

This trial looked azacitidine tablets and best supportive care for acute myeloid leukaemia that was in remission. This means people had no signs of leukaemia after initial treatment.

The trial was open for people to join between 2013 and 2017. The team published the results in 2020. There is a link to more information in the ‘Summary of results’ section below.

More about this trial

Doctors usually treat acute myeloid leukaemia (AML) with chemotherapy. The aim of this is to get the leukaemia into remission Open a glossary item. This means there are no leukaemia cells in the blood or bone marrow Open a glossary item.

People in remission have regular tests and check ups. They have treatment to manage symptoms if they need to. Doctors call this best supportive care (BSC). It includes things such as:

  • blood transfusions 
  • growth factors to increase the number of blood cells 
  • antibiotics to treat infections

But there is a risk that the leukaemia will come back. This is called recurrence. 

In this trial, researchers wanted to find out if azacitidine tablets could help stop leukaemia coming back.  When this trial was done, azacitidine was already being used for people with AML who weren’t able to have more intensive chemotherapy. This was usually through a drip into a vein. 

The people taking part in this trial were all in complete remission. They were put into 1 of 2 groups at random:

  • half had best supportive care and azacitadine tablets
  • half had best supportive care and dummy (placebo) tablets

The main aims of the trial were to find out:

  • if azacitidine tablets help stop AML coming back
  • more about the side effects 
  • how having azacitidine affects people’s quality of life

Summary of results

We aim to add a lay summary of results to all the trials on our database. Unfortunately we have not been able to include a summary for this one.

There is more information about the results in the link below.

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission
Andrew H. Wei and others
New England Journal of Medicine, 2020. Issue 383, pages 2526-2537

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 Mike Dennis

Supported by

Celgene
NIHR Clinical Research Network: Cancer

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11116

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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