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RecruitingNAINTERVENTIONAL

Granulocyte Transfusions After Umbilical Cord Blood Transplant

This study investigates a new approach for children with leukaemia that hasn't responded well to standard treatments. These children sometimes receive a stem cell transplant using umbilical cord blood from an unrelated baby. Researchers have noticed that giving certain white blood cell transfusions, called granulocytes, during these transplants might help the new immune system grow stronger and faster. This could potentially help fight the leukaemia more effectively and reduce other problems. The study aims to understand if these granulocyte transfusions are safe, how they help the immune system, and what impact they have on the leukaemia and other side effects, like when the new immune system attacks healthy body parts.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Manchester
Enrolment target
40
Start
14 Sep 2021
Estimated completion
01 Jun 2026

What is this study about?

For most children with leukaemia, treatments like chemotherapy work very well. However, for some children, the leukaemia can be very tough to treat or might return after initial treatments. In these cases, a special procedure called a stem cell transplant offers another chance at a cure. This involves replacing the child's diseased blood-making cells with healthy ones.

One type of stem cell transplant uses blood collected from the umbilical cord and placenta after a baby is born. This "cord blood" comes from a healthy, unrelated donor. Doctors have observed that when children receive a cord blood transplant, along with transfusions of particular white blood cells called granulocytes, the new immune system from the donor seems to grow much faster than usual. This faster-acting immune system might be better at finding and fighting the leukaemia cells.

This study wants to learn more about this. We will be carefully observing children with difficult-to-treat leukaemia who receive a cord blood transplant and also get these granulocyte transfusions. We'll be checking to make sure the transfusions are safe and understanding how they help the new immune system grow. We also want to see if this approach helps in fighting the leukaemia and if it reduces the risk of other issues, such as the new immune cells mistakenly attacking healthy parts of the body.

Key takeaways

  • The study helps children with leukaemia that hasn't responded to other treatments.
  • It uses cord blood transplant combined with special white blood cell transfusions (granulocytes).
  • Researchers want to see if these transfusions help the new immune system fight cancer.
  • Safety of the transfusions and their effect on leukaemia will be carefully checked.
  • The study aims to improve outcomes for children with difficult-to-treat leukaemia.

Who may be eligible?

To join this study, children must be under 16 years old and have a type of acute leukaemia that is hard to treat or has come back after previous treatments. They need to be planned for their first type of stem cell transplant, using cord blood from an unrelated donor. The cord blood needs to be a good match for the child and contain enough special cells.

It's also important that a parent or guardian gives their full permission for the child to take part. For older children, their agreement will also be asked for.

Children cannot join if they have already had a similar cord blood transplant, are in another stem cell transplant study, or if their doctors decide that receiving the granulocyte transfusions is not safe for them for any medical reason, including past reactions to such transfusions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is my child under 16 years old?
  2. Does my child have a type of acute leukaemia that is difficult to treat or has come back?
  3. Is my child planned to have their first cord blood transplant from an unrelated donor?
  4. Do we understand and agree to the study requirements?
  5. Has my child never had a bad reaction to similar blood transfusions?
Answer every question to see your result.

What does participation involve?

If your child takes part, they will receive granulocyte transfusions as part of their cord blood transplant treatment. Researchers will closely monitor your child's health, including taking regular blood tests to see how their new immune system is developing and to check for any side effects. They will also be looking at how the leukaemia responds to the treatment. The total duration of follow-up will depend on the child's treatment journey, but these checks are a normal part of any transplant process, with additional detailed monitoring for the study.

Potential risks and benefits

Potential benefits of taking part could include a chance for these special white blood cell transfusions to help your child's new immune system fight the leukaemia more effectively. However, as with any medical treatment, there are potential risks, including side effects from the granulocyte transfusions, which will be carefully monitored. You are free to withdraw your child from the study at any time without affecting their standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal Manchester Childrens Hospital, MFT
    Verified postcode
    Manchester, United Kingdom· Recruiting

Common questions

What are granulocytes?

Granulocytes are a type of white blood cell that are very important for fighting infections in the body.

What is a cord blood transplant?

It's a type of stem cell transplant using healthy blood-forming cells collected from a baby's umbilical cord after birth to replace unhealthy ones.

What is leukaemia?

Leukaemia is a type of cancer that affects the blood and bone marrow, leading to too many unhealthy white blood cells.

Will my child still receive their usual treatment?

Yes, their cord blood transplant and other necessary treatments will proceed as planned, with the granulocyte transfusions as an added part of the study.

What is 'graft versus host disease' (GVHD)?

GVHD is a potential complication after a transplant where the new immune cells from the donor see the patient's body as 'foreign' and attack it.

How to find out more

Robert Wynn, MD FRCPath

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Granulocyte Transfusions After Umbilical Cord Blood Transpla…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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