Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05567289 |
Other study ID # |
IRAS ID: 262284 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 6, 2023 |
Est. completion date |
August 2028 |
Study information
Verified date |
June 2023 |
Source |
University of Manchester |
Contact |
Mark Williams |
Phone |
+441613063240 |
Email |
mark.williams-4[@]cruk.manchester.ac.uk |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Precision Medicine for Stem Cell Transplantation (PM-SCT) is a prospective cohort study of
patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT). The study
aims to develop novel biomarkers that predict the onset of acute graft-versus-host disease
(aGvHD) and post-transplant relapse of acute myeloid leukaemia (AML). The study will also
build a collection of clinically annotated longitudinal blood samples from 300 HSCT
recipients to support additional mechanistic research and provide a resource to the
transplant research community.
Patients will be recruited and consented prior to admission for HSCT. 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. Samples will be collected, processed, and stored by the MCRC Biobank. The
period of observation for each patient is 6-months. Clinical data will be collected
prospectively: on admission, with each blood sample, and at 6-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 aims to identify all patients who develop aGvHD, collecting an
additional blood sample at the onset of treatment for those who receive systemic
corticosteroids (PO or IV steroid equivalent to ≥0.5mg/kg prednisolone). Additional clinical
data will be collected at treatment onset and 7, 14, 21 and 28 days after starting systemic
corticosteroids. These assessments will provide the clinical data necessary to establish
diagnostic confidence, severity at onset/peak, response to treatment and outcome.