
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
This study is comparing 2 treatments for myelodysplastic syndromes to increase the number of .
Myelodysplastic syndromes (MDS) are a group of blood cancers. This group of conditions causes a drop in the number of blood cells.
This study is for people who:
Myelodysplastic syndromes are also called myelodysplasia or MDS for short. In some people, MDS can develop into . This study is for people whose MDS has a very low, low or moderate risk of turning into leukaemia.
You might have erythropoietin (EPO) to treat MDS. It helps your body to make more . This works for some people but sometimes it stops working or doesn’t work at all. There are also very few treatments for people with low
and low
. So doctors are looking for treatments to help people who have low blood counts.
They are looking at drugs used for some other illnesses and other cancers to see if they help. In this study, researchers are looking at a combination of treatment called VBaP. This includes:
The researchers are comparing VBaP with another drug called danazol.
We know from earlier research that bezafibrate and medroxyprogesterone increased the number of blood cells in people who have acute myeloid leukaemia. Doctors think that adding sodium valproate to these 2 drugs could increase the number of blood cells even more.
Danazol is a treatment to help people with low blood counts. It stops the cells in the bone marrow from ageing. This allows them to make blood cells for longer. Newer studies suggest it could work well for people with MDS.
The main aims of the study are to find out:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this study if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this study if any of these apply. You:
This phase 2 study is taking place in the UK. The team need about 120 people to take part.
It is a randomised study. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 treatment groups.
You have 1 of the following:
How you have treatment
You start on a low dose of treatment. Your doctor will slowly increase the dose if treatment is working and the side effects aren’t too bad.
Sodium valproate is a tablet. You take them twice a day.
Bezafibrate is a tablet. You take them 3 times a day.
Medroxyprogesterone is a tablet. You take them twice a day.
Danazol is a tablet. You take them 3 times a day.
You have treatment for up to one year as long as it is working and the side effects aren’t too bad.
Samples for research
The researchers will ask for some extra samples of when you have a bone marrow test done. They will also ask to take some extra blood samples. You have these at the same time as your routine blood tests.
They plan to use the samples to see how treatment affects the blood and bone marrow.
You can say no to giving these samples for research and still take part in the main study.
Quality of life
The study team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
Diary
The study team ask you to complete a diary to record when you take your medication and how many tablets you take. This helps them to check you are taking it correctly. It also helps you to know what dose you should be taking.
You see the doctor and have some tests before you can take part. These include:
You have regular blood tests and check ups with your doctor. You will be asked to have another bone marrow test:
The team call you about 4 to 6 weeks after you finish treatment to see how you are.
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if you have any side effects.
The most common side effects of sodium valproate include:
The most common side effects of bezafibrate include:
The most common side effects of medroxyprogesterone include:
The possible side effects of danazol include:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Stephen Jenkins
Professor Janet Dunn
Dr Manoj Raghavan
Blood Cancer UK
The Dudley Group NHS Foundation Trust
University of Warwick
The University of Birmingham
MDS UK Patient Support Group
You can see a map of where this study is taking place on the REPAIR-MDS trial website.
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.”