Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of stem cell transplants using umbilical cord blood (RIC UCBT)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Blood cancers
Children's cancers
Hodgkin lymphoma
Leukaemia
Lymphoma
Myeloma
Non-Hodgkin lymphoma
Status:
Closed
Phase:
Phase 2
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.
Who can enter
You can enter this trial if you
- Have a cancer of the bone marrow or lymphatic system such as leukaemia or lymphoma, and your doctors think reduced intensity conditioning, followed by a stem cell transplant would help you
- Do not have a family member who is suitable as a stem cell donor, and your doctors have not been able to find a matched unrelated donor
- Have already had a bone marrow or stem cell transplant using your own cells (
autologous transplant ) or have had chemotherapy using a combination of drugs in the last 6 months - Are well enough to take part in the trial
- Are willing to use a reliable form of barrier contraception during the treatment and for at least a year afterwards if there is any chance you or your partner could become pregnant
- Are at least 2 years old, but no more than 70 years old
You cannot enter this trial if you
- Have a family member who could donate stem cells to you, or a matched unrelated donor
- Can have any other treatment that your doctors think will cure your disease or keep it under control for a long time
- Have chronic myeloid leukaemia (CML) in the chronic phase and the drug imatinib is helping you
- Have CML that is in blast crisis and is not responding to treatment
- Have
acute leukaemia that has got worse or come back despite treatment and more than 5% of your bone marrow is made up of undeveloped blood cells (blasts) - Have had a bone marrow transplant with high dose chemotherapy in the last 6 months
- Have already had a lot of radiotherapy (the trial doctor can advise you about this)
- Have any type of blood, bone marrow or lymphatic system cancer that is no longer responding to any treatment
- Have conditions affecting the bone marrow called myelofibrosis or acquired aplastic anaemia
- Were born with a condition that makes it more difficult for you fight infections (congenital immune deficiency)
- Have an infection that cannot be controlled with medication
- Have either the HIV or HTLV virus
- Are pregnant or breastfeeding
Trial design
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.
Hospital visits
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine test
- Bone marrow test
- Heart trace (
ECG ) and a heart scan (echocardiogram ) - Chest X-ray
- Tests to see how well your lungs work (
lung function tests )
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
- At least once a week for the first 3 months
- At least once a month for the rest of the first year
The trial doctors will follow your progress for at least 2 years.
Side effects
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
- Sickness
- Sore mouth
- High temperature
- Hair loss
- Diarrhoea
- Inflammation of the bladder
- Skin reactions
- Cataracts
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.
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
Dr Rachel Hough
Supported by
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
Last review date
CRUK internal database number:
Oracle 3110
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Around 1 in 5 people take part in clinical trials
