RecruitingNCT05567289

Precision Medicine for Stem Cell Transplantation


Sponsor

University of Manchester

Enrollment

300 participants

Start Date

Jun 6, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

A study of patients undergoing haematopoietic stem cell transplantation, a procedure in which patients are infused with stem cells from a donor, resulting in a new immune system that eliminates cancer or replaces diseased bone marrow. This study aims to develop new blood tests that predict the onset of acute graft-versus-host disease (aGvHD) and leukaemia relapse, two life-threatening complications that frequently limit the success of treatment. Predictive tests would allow doctors to individualise prophylaxis and intervene early to abort complications before they develop. The study will also create a large collection of clinically annotated blood samples from 300 transplant recipients to support future research and provide a resource to the transplant research community.


Eligibility

Inclusion Criteria3

  • Any recipient of allogeneic haematopoietic stem cell transplantation (HSCT)
  • Children/infants may participate, there is no age restriction
  • Patients participating in other clinical trials remain eligible

Exclusion Criteria2

  • Weight \<5kg
  • Recipients of autologous stem cell transplants

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Interventions

PROCEDUREBlood sample collection

Enrolled patients will undergo sequential blood collection beginning prior to conditioning, then on the day of transplant (day 0), followed by days 7, 14, 21, 28, 56 (2 months) and 90 (3 months) post-transplant. Bone marrow aspirates taken within this period as part of routine care will also be collected, these are typically performed around day 100 and whenever there is suspicion of disease recurrence. The study will also collect an additional blood sample at the onset of treatment for aGvHD for those who receive systemic corticosteroids (PO or IV steroid equivalent to ≥0.5mg/kg prednisolone).

PROCEDUREBone marrow aspirate

Bone marrow aspirates taken within this period as part of routine care will also be collected, these are typically performed around day 100 and whenever there is suspicion of disease recurrence.


Locations(3)

Manchester Royal Infirmary

Manchester, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

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NCT05567289


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