A study looking at stem cell transplants from half matched donors for people with blood cancers (UK Haplo)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at using donor stem cells from a family member who is at least a 50% match with the person having the stem cell transplant.
More about this trial
Doctors have used stem cell transplants for many years to treat cancers of the blood, 
and lymphatic system. When they use the stem cells from the person themselves this is called an . When the stem cells come from someone else (a donor), this is called an .
In most allogeneic transplants the donor is someone who is a very close match to the person having the transplant. This is most usually a brother or sister. It could also be from a donor who isn’t a relative. But doctors can’t find a close match for about a third of those needing a transplant.
An option for these people is called a half matched transplant (haploidentical transplant). This is where the donor is at least a 50% match with the person having the transplant. In the past these transplants have been difficult to do. You can react to the donor cells causing a severe . But researchers think they have found a way to deal with this by using a drug called cyclophosphamide.
When donor cells are transplanted into the body, the body’s immune system recognises them as being from outside the body. So the immune cells start to multiply in order to attack the donor cells. By giving cyclophosphamide at a high dose the researchers hope that it will kill the immune cells and reduce long term side effects.
As a part of this study, some people will get cells from their donor twice. The first is an infusion of white blood cells called . The 2nd is a stem cell transplant.
The aims of this study are to find out
- How well high dose cyclophosphamide works with a half matched stem cell transplant
- How safe high dose cyclophosphamide is for people having a half matched stem cell transplant
- About the side effects
- What the
quality of life is for these people
Who can enter
You may be able to enter this study if
- You have cancer of the blood, bone marrow or lymphoma
- Your doctor considers you to be suitable for a stem cell transplant
- You have a donor who is a family member with at least a 50% match to you
- You have had chemotherapy in the 3 months before agreeing to take part in this study. You may be able to take part if this doesn't apply and your doctor feels you are suitable for a transplant
- You can mostly take care of yourself (Karnofsky performance status 60 to 100)
- You are willing to use reliable contraception during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
- You are between 16 and 70 years old
You cannot enter this study if you
- Have had a transplant of your own stem cells in the past 3 months
- Are not able to have radiotherapy to your whole body (
total body irradiation ) - Have had a donor transplant that wasn’t successful
- Have a HLA matched donor – you can ask your doctor about this
- Have an uncontrolled infection. You may be able to take part if your doctor feels you are suitable for a transplant
- Have another medical condition that could affect you taking part in this trial. You may be able to take part if your doctor feels you are suitable for a transplant
- Are pregnant or breastfeeding
Trial design
This is a phase 2 study. It will recruit 78 people. There are 2 pathways in this study. Your doctor will talk to you about both of these pathways and then both of you can decide which is best for you. The pathways are
- Whole body radiotherapy (total body irradiation), lymphocyte infusion, high dose cyclophosphamide, stem cell transplant
- Fludarabine and low dose cyclophosphamide, total body irradiation, stem cell transplant and high dose cyclophosphamide - Please note this arm of the trial is closed as there enough people in this group
If you are in the group having the lymphocyte infusion and stem cell transfusion, your donor will have their cells collected on 2 separate occasions.
You will be in hospital for your treatment. For several weeks after you leave hospital, you take drugs that damp down your immune system.
The trial team will ask you to fill out a questionnaire:
- before your transplant
- around 3 months (100 days) after your transplant
- around 6 months (180 days) after your transplant
- 1 year after your transplant
- 2 years after your transplant
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor to have some tests before taking part in this study. These tests include
- A physical examination
- Blood tests
- Chest X-ray
- Heart trace (
ECG ) - Heart scan (
ECHO or MUGA ) Breathing tests - Bone marrow test
You will be in hospital for your treatment and stay there until you recover.
After your transplant you see your doctor every week for 2 months. At these appointments, you have a physical examination and blood tests.
Side effects
The most common side effects of fludarabine are
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Fever
- Sore mouth
- Diarrhoea
- Confusion
- Nerve damage
The most common side effects of cyclophosphamide are
- A drop in blood cells
- Feeling or being sick
- Hair loss
- Inflammation of the bladder
The most common side effects of whole body radiotherapy (total body irradiation) are
- A drop in blood cells
- Feeling or being sick
- Loss of appetite
- Skin reactions
- Clouding of the lens of the eye (
cataracts )
The side effects of a stem cell transplant include
- Infection
- Graft versus host disease (GVHD)
We have more information about
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.
Chief Investigator
Dr Kavita Raj
Supported by
Bloodwise
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
