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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
Patient to receive pooled granulocytes for 7 days concurrently. 10 participants will be approached for this arm.
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.
- 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.
- 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.
- 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
- 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
- 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
- How many patients enter flow and molecular remission after the transplant? [ Time Frame: 2 years ]
- 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 ]
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
|Contact: Robert Wynn, MD FRCPathemail@example.com|
|Contact: Roisin Borrill, MRCPCHfirstname.lastname@example.org|
|Study Chair:||Robert Wynn, MD FRCPath||Royal Manchester Children's Hospital|