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

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

Phase:

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
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

A physical examination
Blood tests
Heart trace (ECG )
Bone marrow test

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

A drop in blood cells causing an increased risk of infection, bleeding and bruising
Feeling or being sick
Redness and pain at the injection site
Tiredness
Weakness
Swollen, sore nasal passages
Sore throat
Chest pain
Dizziness
Headache
Rash
Loss of appetite

The most common side effects of romidepsin can include

Feeling or being sick
Diarrhoea or constipation
Loss of appetite
Tiredness
A drop in blood cells causing an increased risk of infection, bleeding, bruising and shortness of breath
Infections
Changes to your heartbeat
Changes to the way your liver works
Swollen hands or feet
Weight loss
Taste changes
Cough
Rash, itchy skin
Low blood pressure