Status:
RECRUITING
Granulocyte Transfusions After Umbilical Cord Blood Transplant
Lead Sponsor:
University of Manchester
Collaborating Sponsors:
Children's Cancer and Leukaemia Group
Conditions:
Pediatric Cancer
Eligibility:
All Genders
Up to 16 years
Phase:
NA
Brief 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 othe...
Detailed Description
Most children with acute leukaemia are cured with chemotherapy alone but a few children are either refractory to such therapy, or relapse after it has been administered. Some of these relapsed or ref...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients participating in other HSCT clinical trial
- The transplant not indicated according to National Health Service England (NHSE) and British Society of Bone Marrow Transplant (BSBMT) Paediatric Transplant Group.
- Pooled Granulocyte Transfusion contraindicated for any reason
- 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
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05425043
Start Date
September 14 2021
End Date
June 1 2026
Last Update
October 2 2024
Active Locations (1)
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1
Royal Manchester Childrens Hospital, MFT
Manchester, United Kingdom, M13 9WL