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Contact Information:

Robert Wynn, MD FRCPath 01617018417
robert.wynn@mft.nhs.uk


Roisin Borrill, MRCPCH 01617018417
roisin.borrill@mft.nhs.uk


Study Location:

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Be Part of Research - Trial Details - Granulocyte Transfusions After Umbilical Cord Blood Transplant

Granulocyte Transfusions After Umbilical Cord Blood Transplant

Recruiting

Open to: ALL

Age: N/A - 16.0

Medical Conditions


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Sep 2021 Jun 2026

Publications

"Keating AK, Langenhorst J, Wagner JE, et al. The influence of stem cell source on transplant outcomes for pediatric patients with acute myeloid leukemia. Blood Adv. 2019;3(7):1118-1128. Blood Adv. 2020 Mar 24;4(6):1081. doi: 10.1182/bloodadvances.2020001753. No abstract available."; "32196555"; "Deambrosis D, Lum SH, Hum RM, Poulton K, Ogden W, Jones S, Stanworth S, Bonney D, Hiwarkar P, Wynn RF. Immune cytopenia post-cord transplant in Hurler syndrome is a forme fruste of graft rejection. Blood Adv. 2019 Feb 26;3(4):570-574. doi: 10.1182/bloodadvances.2018026963."; "30787020"; "Lum SH, Miller WP, Jones S, Poulton K, Ogden W, Lee H, Logan A, Bonney D, Lund TC, Orchard PJ, Wynn RF. Changes in the incidence, patterns and outcomes of graft failure following hematopoietic stem cell transplantation for Hurler syndrome. Bone Marrow Transplant. 2017 Jun;52(6):846-853. doi: 10.1038/bmt.2017.5. Epub 2017 Feb 20."; "28218755"; "Eapen M, Wang T, Veys PA, Boelens JJ, St Martin A, Spellman S, Bonfim CS, Brady C, Cant AJ, Dalle JH, Davies SM, Freeman J, Hsu KC, Fleischhauer K, Kenzey C, Kurtzberg J, Michel G, Orchard PJ, Paviglianiti A, Rocha V, Veneris MR, Volt F, Wynn R, Lee SJ, Horowitz MM, Gluckman E, Ruggeri A. Allele-level HLA matching for umbilical cord blood transplantation for non-malignant diseases in children: a retrospective analysis. Lancet Haematol. 2017 Jul;4(7):e325-e333. doi: 10.1016/S2352-3026(17)30104-7. Epub 2017 Jun 13."; "28623181"; "Veys P, Danby R, Vora A, Slatter M, Wynn R, Lawson S, Steward C, Gibson B, Potter M, de la Fuente J, Shenton G, Cornish J, Gennery A, Snowden JA, Bonney D, Velangi M, Ruggeri A, Gluckman E, Hough R, Rocha V; British Society of Blood and Marrow Transplantation and Eurocord. UK experience of unrelated cord blood transplantation in paediatric patients. Br J Haematol. 2016 Feb;172(3):482-6. doi: 10.1111/bjh.13914. Epub 2016 Jan 5. No abstract available."; "26728432"; "Boelens JJ, Aldenhoven M, Purtill D, Ruggeri A, Defor T, Wynn R, Wraith E, Cavazzana-Calvo M, Rovelli A, Fischer A, Tolar J, Prasad VK, Escolar M, Gluckman E, O'Meara A, Orchard PJ, Veys P, Eapen M, Kurtzberg J, Rocha V; Eurocord; Inborn Errors Working Party of European Blood and Marrow Transplant group; Duke University Blood and Marrow Transplantation Program; Centre for International Blood and Marrow Research. Outcomes of transplantation using various hematopoietic cell sources in children with Hurler syndrome after myeloablative conditioning. Blood. 2013 May 9;121(19):3981-7. doi: 10.1182/blood-2012-09-455238. Epub 2013 Mar 14."; "23493783"; "Aldenhoven M, Jones SA, Bonney D, Borrill RE, Coussons M, Mercer J, Bierings MB, Versluys B, van Hasselt PM, Wijburg FA, van der Ploeg AT, Wynn RF, Boelens JJ. Hematopoietic cell transplantation for mucopolysaccharidosis patients is safe and effective: results after implementation of international guidelines. Biol Blood Marrow Transplant. 2015 Jun;21(6):1106-9. doi: 10.1016/j.bbmt.2015.02.011. Epub 2015 Feb 20."; "25708213"; "Takami A. Hematopoietic stem cell transplantation for acute myeloid leukemia. Int J Hematol. 2018 May;107(5):513-518. doi: 10.1007/s12185-018-2412-8. Epub 2018 Jan 27."; "29374826"; "Milano F, Gooley T, Wood B, Woolfrey A, Flowers ME, Doney K, Witherspoon R, Mielcarek M, Deeg JH, Sorror M, Dahlberg A, Sandmaier BM, Salit R, Petersdorf E, Appelbaum FR, Delaney C. Cord-Blood Transplantation in Patients with Minimal Residual Disease. N Engl J Med. 2016 Sep 8;375(10):944-53. doi: 10.1056/NEJMoa1602074."; "27602666"; "Hiwarkar P, Qasim W, Ricciardelli I, Gilmour K, Quezada S, Saudemont A, Amrolia P, Veys P. Cord blood T cells mediate enhanced antitumor effects compared with adult peripheral blood T cells. Blood. 2015 Dec 24;126(26):2882-91. doi: 10.1182/blood-2015-06-654780. Epub 2015 Oct 8."; "26450984"; "Admiraal R, Chiesa R, Lindemans CA, Nierkens S, Bierings MB, Versluijs AB, Hiwarkar P, Furtado Silva JM, Veys P, Boelens JJ. Leukemia-free survival in myeloid leukemia, but not in lymphoid leukemia, is predicted by early CD4+ reconstitution following unrelated cord blood transplantation in children: a multicenter retrospective cohort analysis. Bone Marrow Transplant. 2016 Oct;51(10):1376-1378. doi: 10.1038/bmt.2016.116. Epub 2016 May 9. No abstract available."; "27159172"; "Chiesa R, Gilmour K, Qasim W, Adams S, Worth AJ, Zhan H, Montiel-Equihua CA, Derniame S, Cale C, Rao K, Hiwarkar P, Hough R, Saudemont A, Fahrenkrog CS, Goulden N, Amrolia PJ, Veys P. Omission of in vivo T-cell depletion promotes rapid expansion of naive CD4+ cord blood lymphocytes and restores adaptive immunity within 2 months after unrelated cord blood transplant. Br J Haematol. 2012 Mar;156(5):656-66. doi: 10.1111/j.1365-2141.2011.08994.x. Epub 2012 Jan 9."; "22224700"; "Politikos I, Lavery JA, Hilden P, Cho C, Borrill T, Maloy MA, Giralt SA, van den Brink MRM, Perales MA, Barker JN. Robust CD4+ T-cell recovery in adults transplanted with cord blood and no antithymocyte globulin. Blood Adv. 2020 Jan 14;4(1):191-202. doi: 10.1182/bloodadvances.2019000836."; "31935291"; "Estcourt LJ, Stanworth SJ, Hopewell S, Doree C, Trivella M, Massey E. Granulocyte transfusions for treating infections in people with neutropenia or neutrophil dysfunction. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD005339. doi: 10.1002/14651858.CD005339.pub2."; "27128488"; "Massey E, Harding K, Kahan BC, Llewelyn C, Wynn R, Moppett J, Robinson SP, Green A, Lucas G, Sadani D, Liakopoulou E, Bolton-Maggs P, Marks DI, Stanworth S. The granulocytes in neutropenia 1 (GIN 1) study: a safety study of granulocytes collected from whole blood and stored in additive solution and plasma. Transfus Med. 2012 Aug;22(4):277-84. doi: 10.1111/j.1365-3148.2012.01152.x. Epub 2012 May 16."; "22591484"; "Hiwarkar P, Adams S, Gilmour K, Nataraj R, Bonney D, Poulton K, Wynn R. Cord blood CD8+ T-cell expansion following granulocyte transfusions eradicates refractory leukemia. Blood Adv. 2020 Sep 8;4(17):4165-4174. doi: 10.1182/bloodadvances.2020001737."; "32886752"; "Bashir S, Stanworth S, Massey E, Goddard F, Cardigan R. Neutrophil function is preserved in a pooled granulocyte component prepared from whole blood donations. Br J Haematol. 2008 Mar;140(6):701-11. doi: 10.1111/j.1365-2141.2008.06996.x."; "18302716"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Receive granulocytes for 7 consecutive days after engraftment post transplant

Intervention Arm Group : Granulocytes;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Manchester Childrens Hospital, MFT
    Manchester
    M13 9WL

Roisin Borrill, MRCPCH 01617018417
roisin.borrill@mft.nhs.uk


Robert Wynn, MD FRCPath 01617018417
robert.wynn@mft.nhs.uk



The study is sponsored by University of Manchester and is in collaboration with Children's Cancer and Leukaemia Group.




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Read full details for Trial ID: NCT05425043
Last updated 30 September 2024

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