
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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.
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 () 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
You may be able to enter this trial if you
You cannot enter this trial if you
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.
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.
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Charles Craddock
Bloodwise
Celgene Ltd
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”