A trial looking at romidepsin and azacitidine for acute myeloid leukaemia (ROMAZA)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers




Phase 1/2

This trial is looking at a new drug called romidepsin (roe-mi-dep-sin) for people with acute myeloid leukaemia. This trial is for people who can’t have standard chemotherapy treatment for AML.


More about this trial

Doctors usually treat acut myeloid leukaemia (AML) with chemotherapy. Some people may not be able to have the standard chemotherapy for AML. So doctors are always looking for new treatments for these people.

Azacitidine is a chemotherapy drug that doctors already use to treat people with AML.

Romidepsin is a drug that blocks substances (enzymes Open a glossary item) in the body called histone deacetylases (pronounced dee-as-et-isle-azes). Cells need these to grow and divide. Blocking them may stop cancer growing. Drugs that block these enzymes are called histone deacetylase inhibitors or HDAC inhibitors. We know from research that other HDAC inhibitors can help people with other types of cancers.

The researchers think that the combination of romidepsin and azacitidine may help people with AML who can’t have standard chemotherapy treatment.

The aims of this trial are to find out

  • What is the highest dose of romidepsin to give with azacitidine
  • How safe it is to give romidepsin with azacitidine
  • How well this combination of drugs work for people with AML

Who can enter

You may be able to enter this trial if you

  • Have acute myeloid leukaemia (AML)
  • Aren’t able to have the standard chemotherapy treatment for AML
  • Are able to have your treatment as an outpatient Open a glossary item
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood tests results
  • Are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
  • Are at least 16 years old

You cannot enter this trial if you

  • Have acute promyelocytic leukaemia (APL)
  • Are in the blast transformation phase
  • Have had a heart attack in the past 6 months or another serious heart problem
  • Have high blood pressure that isn’t controlled by medication
  • Have another cancer
  • Have an infection
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Have taken an experimental drug as part of a clinical trial in the past month
  • Have any other medical condition that could affect you taking apart in this trial
  • Are allergic to azacitidine, romidepsin or their ingredients
  • Are pregnant or breastfeeding

Trial design

This is a phase 1/2 trial. It will recruit about 50 people. Everyone will have azacitidine and romidepsin.

The first few people will have a low dose of romidepsin with azacitidine. If they don’t have any serious side effects the next few people will have a higher dose. And so on until they find the best dose to give. This is called a dose escalation study. 

Everybody has 4 week cycles of treatment.

You have azacitidine as an injection just under your skin (subcutaneous injections) once a day for 7 days at the beginning of each treatment cycle.

You have romidepsin as an injection into a vein. You have it once a week for 2 weeks of each treatment cycle. You may also need to have it once in week 3.

You have 6 cycles of treatment. But if the treatment is helping and you don’t have any bad side effects, the trial doctors will talk to you about having it for longer.

The researchers will ask for some extra blood samples and 3 extra bone marrow tests. If you don’t want to give these samples, you don’t have to. You can still take part in the trial.

When you start romidepsin, you will have some leukaemia cells in your body. When cancer cells die, chemicals in the cells are suddenly released into your blood. This changes the normal balance of chemicals circulating in your body. This is called tumour lysis syndrome. If this happens your doctor will give you medication to control it.

While taking part in the trial you shouldn’t take certain medications, vitamins, herbal supplements or drink certain juices or green tea. Your doctor will talk to you about this.

Hospital visits

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

During treatment you see the doctor every 4 weeks for the same tests. You have the bone marrow tests every 3 months.

A month after you finish treatment, you see the doctor for a physical examination and blood tests.

Side effects

The most common side effects of azacitidine are

The most common side effects of romidepsin can include

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

We have more information about azacitidine.



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 Charles Craddock

Supported by

Celgene Ltd
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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