NCT05567289|Recruiting
Precision Medicine for Stem Cell Transplantation
PM-SCT
Loading search results
PM-SCT
Sponsor study identifier
observational
300
1 country
3
Study Start
June 6, 2023
Actual (reported)Primary Completion
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2022
Actual (reported)October 5, 2022
Actual (reported)June 6, 2023
Actual (reported)August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Development of biomarkers that predict the onset of acute graft-versus-host disease (aGvHD)
GvHD staging in this study is based on the approach of Harris et al., (2016). The weekly aGvHD assessments will provide the clinical data necessary to establish the confidence of diagnosis, severity at onset, peak severity and outcome. Four weeks of follow-up will determine whether patients achieve a complete response (CR) or very good partial response (VGPR) by day 28. In addition, the 6-month assessment will identify patients who died as a result of aGvHD and those who are alive and off immunosuppression at six months. These validated clinical endpoints will be used to identify biomarker signatures that predict aGvHD severity and response to therapy. Calendar-driven assessments will also be used to identify patients given topical steroids for grade I aGvHD as these patients may need to be excluded from use as negative controls or included as edge cases in future validation studies.
5 years
Development of biomarkers that predict the relapse of acute myeloid leukaemia.
2.5 years
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).
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.
Patient undergoing allogeneic haematopoietic stem cell transplantation (HSCT).
Manchester Royal Infirmary
Manchester, m13 9wl, United Kingdom
Royal Manchester Children's Hospital
Manchester, m139wl, United Kingdom
Cryopreserved plasma and peripheral blood mononuclear cells.
Mark Williams
CRUK Manchester Institute
First Submitted
September 28, 2022
First Posted
October 5, 2022
Study Start
June 6, 2023
Actual (reported)Primary Completion
August 2025
Estimated (date passed)Laboratory Studies Into the Pathology of Leukaemia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 3, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: