Actively Recruiting
Granulocyte Transfusions After Umbilical Cord Blood Transplant
Led by University of Manchester · Updated on 2024-10-02
40
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
U
University of Manchester
Lead Sponsor
C
Children's Cancer and Leukaemia Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Although most children with leukaemia are cured using drugs (chemotherapy) alone, for some children additional treatments are needed. Stem cell transplant can cure children where chemotherapy and other drugs have failed. In this case, the immune cells of the donor attack the leukaemia cells of the patient. Cord blood collected from the placenta of unrelated babies is often used as a donor cell source and appears to work well at controlling leukaemia and less likely to cause complications such as when the immune cells also mistakenly attack healthy tissues (called graft versus host disease, GVHD). The investigators have noticed that during cord blood transplant, the donor immune system appears to recover more quickly and not be associated with GVHD, when a type of blood transfusion containing white cells are also given to the patient. The infused white cells appear to stimulate the donor immune cells to expand much more than usually seen. During this research, the investigators will study this immune cell expansion during cord blood transplant in children with difficult-to-cure leukaemia who also receive a transfusion of white cells, termed granulocytes. The investigators will assess the safety of the effects of the white cell transfusions and the immune cell expansion on the child, and look at the outcomes on the patient's leukaemia, and whether there is GVHD or not.
CONDITIONS
Official Title
Granulocyte Transfusions After Umbilical Cord Blood Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children under 16 years old undergoing their first allogeneic, unrelated donor, T-cell replete umbilical cord blood transplant for high-risk acute leukaemia
- Availability of at least a 6/8 allelic matched cord blood unit with adequate cell dose
- Informed consent from parent or guardian; age-appropriate assent for children 16 and under
You will not qualify if you...
- Participation in other hematopoietic stem cell transplant clinical trials
- Transplant not indicated according to NHS England and British Society of Bone Marrow Transplant pediatric guidelines
- Contraindication to pooled granulocyte transfusion
- Previous T-cell replete unrelated donor cord blood transplant
- History of sensitivity to granulocyte transfusions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Royal Manchester Childrens Hospital, MFT
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
R
Robert Wynn, MD FRCPath
CONTACT
R
Roisin Borrill, MRCPCH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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