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Granulocyte Transfusions After Umbilical Cord Blood Transplant

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ClinicalTrials.gov Identifier: NCT05425043
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Children's Cancer and Leukaemia Group
Information provided by (Responsible Party):
University of Manchester

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 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.


Condition or disease Intervention/treatment Phase
Pediatric Cancer Biological: Granulocytes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : September 14, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Granulocytes
Patient to receive pooled granulocytes for 7 days concurrently. 10 participants will be approached for this arm.
Biological: Granulocytes
Receive granulocytes for 7 consecutive days after engraftment post transplant

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. 10 participants will be approached for this arm.



Primary Outcome Measures :
  1. What is the number of patients with grade 1-4 cytokine release syndrome, related to the granulocytes infusions? [ Time Frame: 2 years ]
    This is to access safety of the granulocyte infusions.

  2. What is the number of patients with allo-immunisation after the granulocyte infusions? [ Time Frame: 2 years ]
    This is to access safety of the granulocyte infusions.


Secondary Outcome Measures :
  1. What is the median day to neutrophil and to platelet engraftment, and compared with a control group of cord blood transplant recipients not receiving granulocytes? [ Time Frame: 2 years ]
    This is to measure the effect that the granulocyte infusion course have on engraftment and on the disease

  2. How many patients experience grade II-IV GvHD? [ Time Frame: 2 years ]
    This is to measure the effect that the granulocyte infusion course have on engraftment and on the disease

  3. What is the median disease-free and overall survival in this patient cohort? [ Time Frame: 2 years ]
    This is to measure the effect that the granulocyte infusion course have on engraftment and on the disease

  4. How many patients enter flow and molecular remission after the transplant? [ Time Frame: 2 years ]
    This is to measure the effect that the granulocyte infusion course have on engraftment and on the disease

  5. What is the median date of cessation of immune suppression after the transplant, and compared with a control group of cord blood transplant recipients not receiving granulocytes? [ Time Frame: 2 years ]
    This is to measure the effect that the granulocyte infusion course have on engraftment and on the disease



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05425043


Contacts
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Contact: Robert Wynn, MD FRCPath 01617018417 robert.wynn@mft.nhs.uk
Contact: Roisin Borrill, MRCPCH 01617018417 roisin.borrill@mft.nhs.uk

Locations
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United Kingdom
Royal Manchester Childrens Hospital, MFT Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Robert Wynn, MD FRCPath    01617018417    Robert.Wynn@mft.nhs.uk   
Contact: Roisin Borrill, MRCPCH    01617018417    Roisin.Borrill@mft.nhs.uk   
Sponsors and Collaborators
University of Manchester
Children's Cancer and Leukaemia Group
Investigators
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Study Chair: Robert Wynn, MD FRCPath Royal Manchester Children's Hospital
Publications:

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Responsible Party: University of Manchester
ClinicalTrials.gov Identifier: NCT05425043    
Other Study ID Numbers: 295998
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Manchester:
Granulocytes
HSCT
Haematopoietic Stem Cell Transplant
Pediatric
Leukemia