
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at using umbilical cord blood from unrelated donors for people who have cancer of the bone marrow or lymphatic system. This includes and
.
The trial is for children over the age of 2 and adults up to the age of 70. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.
are cells in the
that grow into new blood cells. If you have high doses of chemotherapy, a lot of the stem cells are damaged and you need a bone marrow or stem cell transplant to replace them.
If you have bone marrow or stem cells from somebody else (a donor), they must have similar bone marrow to you. Some people have a family member who is a match. Other people have a transplant from an unrelated donor. But sometimes, neither type of donor is available. This trial is for people in that situation.
Stem cells can also be collected from the umbilical cord of newborn babies. Many people around the world have donated their baby’s umbilical cords which are stored safely. A number of young children have been treated using these cells, but the largest study was carried out in America and used this type of treatment for adults. Researchers want to see if stem cells from umbilical cord blood can be used to treat both adults and children in this country.
They are using lower doses of treatment than people usually have before a bone marrow or stem cell transplant. This is called ‘reduced intensity conditioning’ (RIC). RIC causes fewer side effects than the high dose treatment so the researchers hope this will allow more people to have the treatment. They think that another possible benefit of using umbilical cord blood is that fewer people will have a problem called graft versus host disease, which is a side effect of having stem cells from a donor.
The aim of the trial is to see if a transplant using cord blood cells helps people who don’t have a stem cell donor.
You can enter this trial if you
You cannot enter this trial if you
The trial will recruit 60 people from around the UK. It will include both adults and children. Everybody taking part will have chemotherapy and radiotherapy before having a transplant of stem cells from the umbilical cord blood of at least one unrelated donor.
To take part in this trial, the researchers need to be sure that there are 1 or 2 lots of cord blood cells that would be suitable for you. They will only use 2 if there is some concern that they won’t get enough cells from one umbilical cord.
You have the chemotherapy drugs cyclophosphamide and fludarabine. You also have one dose of radiotherapy to your whole body. This is called total body irradiation or TBI. Having the chemotherapy and radiotherapy takes 6 days. On the 7th day, you have the stem cells from 1 or 2 units of cord blood, through a drip into a vein.
These cells find their way into your bone marrow where they will start making new blood cells.
You will see the doctors and have some tests before you start treatment. The tests include
You will be in hospital for about 4 to 6 weeks to have this treatment. As you will be at a high risk of infection, you will be in your own room. This is called ‘being in isolation’. You will have another bone marrow test 3 weeks after your transplant.
When you go home, you have to go back to hospital on a regular basis. To begin with, this will probably be 2 or 3 times a week. It is not unusual to have to go back into hospital for a few days at some point.
After a transplant, you will see the doctors and have blood tests
The trial doctors will follow your progress for at least 2 years.
The main side effect of the treatment you have just before the transplant is a drop in the number of blood cells, causing an increased risk of infection, tiredness and breathing problems. It takes longer for blood cells to start growing again after a transplant of cord blood than after other types of stem cell transplant. Even when your blood count gets back to normal, your immune system may take up to 2 years to recover fully.
Other side effects include
We have more information about the side effects of bone marrow and stem cell transplants.
Unfortunately, this treatment may affect you ability to have children (your fertility). Men taking part will be offered the option to store sperm () before starting treatment. Preserving fertility for women is more complicated and it is important that women talk to their doctors about this before starting treatment.
After any type of bone marrow or stem cell transplant, there is a risk of graft versus host disease (GVHD). This happens when the new stem cells attack your body tissue. It mainly affects your skin, gut and liver. The risk of GVHD may be lower with this type of treatment and you will have medicine to try to stop it happening and to treat the symptoms.
Rarely, the new stem cells fail to start working. If this does happen, your own bone marrow will eventually recover and start producing new blood cells, but this will take a long time.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Rachel Hough
British Society for Blood and Marrow Transplantation
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Sue Harris Bone Marrow Trust
University College London (UCL)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.