The Use of Granulocyte Transfusions After Umbilical Cord Blood Transplant for Leukaemia: a Prospective, Non-randomised, Single-centre Study to Evaluate Safety and Immune Reconstitution

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 16
Healthy Volunteers: f
View:

• Children, aged \<16 years, undergoing a first allogeneic, unrelated donor, T-cell replete, umbilical cord blood HSCT for high risk acute leukaemia.

• Availability of at least a 6/8 allelic matched cord blood, of adequate cell dose, after allele-level matching at HLA (Human Leukocyte Antigen)-A, -B, -C, and -DRB1

• Informed consent by parent or guardian. Age appropriate Assent will also be collected in those Children age 16 and under.

Locations
Other Locations
United Kingdom
Royal Manchester Childrens Hospital, MFT
RECRUITING
Manchester
Contact Information
Primary
Robert Wynn, MD FRCPath
robert.wynn@mft.nhs.uk
01617018417
Backup
Roisin Borrill, MRCPCH
roisin.borrill@mft.nhs.uk
01617018417
Time Frame
Start Date: 2021-09-14
Estimated Completion Date: 2026-06
Participants
Target number of participants: 40
Treatments
Experimental: Granulocytes
Patient to receive pooled granulocytes for 7 days concurrently. 20 participants will be approached for this arm.
No_intervention: Control
Non-randomised control arm, where patients who are receiving a stem cell transplant, as described in the eligibility criteria, are asked for a blood sample. This is to establish a baseline versus the experimental arm. 20 participants will be approached for this arm.
Related Therapeutic Areas
Sponsors
Leads: University of Manchester
Collaborators: Children's Cancer and Leukaemia Group

This content was sourced from clinicaltrials.gov

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