IFNg-study
Research type
Research Study
Full title
A clinical study to investigate Interferon gamma (IFNɣ) signature in patients post HSCT and in patients with impaired HSC proliferation pre-transplant
IRAS ID
290322
Contact name
Renuka Palanicawandar
Contact email
Sponsor organisation
Swedish Orphan Biovitrum AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 29 days
Research summary
Research Summary
This multinational interventional non drug study is designed to measure proteins ( Interferon gamma (IFNγ) and C-X-C motif chemokine ligand 9 (CXCL9)) in patient’s blood. These proteins called cytokines are believed to take part in the process responsible for graft failure (GF) or the process limiting Hematopoietic Stem Cell (HSC) proliferation. The aim of this study is to investigate the role of these proteins in these processes
This research study is designed to measure these proteins in two groups of patients.
First group will include patients post Hematopoietic Stem Cell Transplantation (HSCT) at risk of graft failure defined based on their underlying diseases and on the transplant procedure. Second group will contain patients with conditions where Hematopoietic Stem Cell (HSC) proliferation is impaired (e.g. aplastic anemia)
The study results and samples collected will support the development of future interventional studies with emapalumab in new indications and the establishment of assays necessary to support the development of emapalumab.
Approximately between 100 and 300 patients and 15 healthy volunteers will participate in this study in 6 countries.
In the first group (HSCT), the blood samples will be collected during the routine clinic stay starting 7 days before the transplant and up to 42 days after the transplant. If Graft Failure (GF) occurs an additional blood samples will be collected up to 100 days after transplant.
In the second group (impaired HSC proliferation), the study will last 1 day and one blood sample will be collected within not more than 1 week from the date of diagnosis.
Participation in this study is not intended to change the routine treatment that patients receive as determined by their prescribing clinicians. No additional visits to the clinic will be required for the purposes of the study.Summary of results
Only 5 of 86 patients with pGF were observed in this study and no patient with sGF. All patients with GF had an elevated CXCL9 prior to GF, but the data does not support the finding that
CXCL9 alone is a good predictor of GF with high sensitivity and PPV, mainly because of the many false positives observed (patients with elevated CXCL9 that did not experience GF).
The rate of observed GF was lower than expected given the inclusion criteria aiming to enrich for the occurrence of GF by selecting patients at elevated risk.
Overall the early termination of the study and the low number of patients, prevent concluding strongly on the predictive characteristics of CXCL9, but suggest that CXCL9 does not appear to be sufficient alone to precisely predict these conditions. However, taken together, these data support a potential role of IFNγ and CXCL9 in GF, GVHD and stem cell proliferation impairment (SAA).REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0104
Date of REC Opinion
20 Aug 2021
REC opinion
Further Information Favourable Opinion