Actively Recruiting

Phase Not Applicable
Age: 0 - 16Years
All Genders
NCT05425043

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

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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

Age: 0 - 16Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Royal Manchester Childrens Hospital, MFT

Manchester, United Kingdom, M13 9WL

Actively Recruiting

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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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