Granulocyte transfusions for children after umbilical cord blood transplant
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
This study tests whether giving white blood cells from donors to children after a cord blood transplant can help them recover better and lower the risk of complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | University of Manchester Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Manchester) |
| Trial ID | NCT05425043 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of granulocyte transfusions in children undergoing umbilical cord blood hematopoietic stem cell transplantation (HSCT) for high-risk acute leukemia. The approach aims to enhance the recovery of the donor immune system and reduce complications such as graft-versus-host disease (GVHD). By administering white blood cells from donors, the researchers hope to stimulate the expansion of the donor's immune cells, improving the chances of a successful transplant. The study focuses on children under 16 years old who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 16 years old with high-risk acute leukemia who are undergoing their first allogeneic umbilical cord blood HSCT.
Not a fit: Patients who are not undergoing HSCT or those with contraindications to granulocyte transfusions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and reduce complications for children with refractory leukemia undergoing HSCT.
How similar studies have performed: While the use of granulocyte transfusions in HSCT is a promising approach, it remains relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Children, aged \<16 years, undergoing a first allogeneic, unrelated donor, T-cell replete, umbilical cord blood HSCT for high risk acute leukaemia. 2. 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 3. Informed consent by parent or guardian. Age appropriate Assent will also be collected in those Children age 16 and under. Exclusion Criteria: 1. Patients participating in other HSCT clinical trial 2. The transplant not indicated according to National Health Service England (NHSE) and British Society of Bone Marrow Transplant (BSBMT) Paediatric Transplant Group. 3. Pooled Granulocyte Transfusion contraindicated for any reason 4. Previous T cell replete unrelated donor cord blood transplant 5. Patients with a previous history of sensitivity to granulocyte transfusion will be excluded from the study
Where this trial is running
Manchester
- Royal Manchester Childrens Hospital, MFT — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Robert Wynn, MD FRCPath
- Email: robert.wynn@mft.nhs.uk
- Phone: 01617018417
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.