NCT05425043Active, not recruiting
Granulocyte Transfusions 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
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 17 Dec 2021
- Start date
- 14 Sept 2021
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University of Manchester
- Diseases
- Childhood cancers
- NCT number
- NCT05425043
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 14 Sept 2021 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The transplant not indicated according to National Health Service England (NHSE) and British Society of Bone Marrow Transplant (BSBMT) Paediatric Transplant Group.
- Previous T cell replete unrelated donor cord blood transplant
- Patients with a previous history of sensitivity to granulocyte transfusion will be excluded from the study
Other
- Patients participating in other HSCT clinical trial
- Pooled Granulocyte Transfusion contraindicated for any reason
Who the study is looking for
- 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.
Age in the registry: - to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Manchester Childrens Hospital, MFT Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.