Purpose of trial
The aim of this trial is to find out if a new treatment to boost stem cell production and bone marrow recovery is safe and effective in people with blood cancers who need stem cell transplants using umbilical cord blood. Umbilical cord blood stem cells are used as an alternative donor source in patients that lack a matched sibling or unrelated donor.
Stem cells are immature blood cells that can develop into all the mature blood cells your body needs (red blood cells, white blood cells and platelets). A stem cell transplant helps your bone marrow recover after high-dose chemotherapy used to treat some types of lymphoma. It is given as a drip (infusion) containing stem cells. It is an intensive treatment and you usually stay in hospital for at least 4 to 6 weeks.
Everybody in this trial has a stem cell transplant using donor (allogeneic) stem cells extracted from umbilical cord blood. Participants are randomised to one of two different types of stem cells:
- Stem cells extracted from donor umbilical cord blood.
- Stem cells extracted from donor umbilical cord blood and then treated in a laboratory with a drug called nicotinamide. This boosts cell division and encourages cells to move from the bloodstream into the bone marrow. The treated stem cells are called NiCord®.
You can’t choose which type of stem cells you have and neither can your doctor. You are told which type you are having and given information about it.
The process of having the stem cell transplant is the same whichever treatment you have.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Around 120 people are needed for this trial.
You may be able to enter if:
- You have lymphoma and you have been told you need an allogeneic (donor) stem cell transplant.
- Umbilical cord blood is available that matches your tissue type.
- A back-up source of stem cells is also available.
- You are well enough to take part in the trial.
- Your blood and other health test results are satisfactory.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- You are 12 or over.
You won’t be able to enter if:
- A matched donor (not using umbilical cord blood) has been found for your stem cell transplant.
- You have had a previous stem cell transplant.
- You have lymphoma or any other illness affecting your central nervous system (CNS; brain and spinal cord).
- You have another cancer.
- You have an active or uncontrolled infection.
- You have HIV, hepatitis C or hepatitis B.
- You are pregnant or breastfeeding.
More information about this trial is available at clinicaltrials.gov/ct2/show/study/NCT02730299