Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02156479
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2014-05-27
Brief Title:
Clinical Validation of Lophius Biosciences Kit T-Track CMV in Allo-HSCT Recipients
Sponsor:
Lophius Biosciences GmbH
Organization:
Lophius Biosciences GmbH
Study Overview
Official Title:
Clinical Validation of an Improved T-Track CMV Assay to Assess the Functionality of CMV Protein-reactive Cell-mediated Immunity CMI and Its Suitability to Determine a Protective Cut-off Value for Recurrent CMV Reactivations in Allo-HSCT Recipients
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AlloProtectCMV
Brief Summary:
This study in a cohort of allo-HSCT recipients aims to validate the suitability of an improved T-Track CMV assay to assess the functionality of CMV protein-reactive effector cells and its suitability to determine cut-off values mediating protection from recurrent CMV reactivations in allo-HSCT recipients
Lophius T-Track CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells It is based on the stimulation of peripheral blood mononuclear cells PBMC with activated immunodominant CMV proteins pp65 and IE-1 and the subsequent quantification of CMV-specific CMI spot forming colonies using a highly sensitive IFN-γ ELISpot
Lophius T-Track CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells It is based on the stimulation of peripheral blood mononuclear cells PBMC with activated immunodominant CMV proteins pp65 and IE-1 and the subsequent quantification of CMV-specific CMI spot forming colonies using a highly sensitive IFN-γ ELISpot
Detailed Description:
CMV reactivation after allogeneic hematopoietic stem cell transplantation allo-HSCT is associated with significant morbidity and increased overall mortality Patients are generally pre-emptively treated with antiviral medication after elevated levels of CMV copies in peripheral blood or plasma have been detected by quantitative PCR However these CMV reactivations are often subclinical and do not lead to complications or CMV disease In these cases functional CMV- specific effector cells have been shown to mediate protection from clinical symptoms Monitoring of CMV- specific effector cells after allo-HSCT could help to prevent severe side effects due to unnecessary antiviral treatment
Since the majority of patients develops more than one episode of CMV reactivation determination of functional CMV-reactive effector cells of cell mediated immunity CMI could also help to predict the likelihood of relapsing CMV reactivations and thereby adjust the need for and duration of secondary prophylaxis
Currently available techniques to measure CMV-specific effector cells lack either a functional read out multimer stain or are time consuming and difficult to standardize detection of intracellular interferon gamma IFN-ᵞ after in vitro stimulation using flow cytometry The improved T-Track CMV assay has the advantage of combining a standardized and highly sensitive test system with a functional read out IFN-ᵞ production considering the function of antigen presenting cells APC and different populations of clinically relevant effector cells CTL T helper- NK- NKT cells Based on experiences of the performance of this assay system in healthy individuals and hemodialysis patients the latter as part of a performance evaluation - EUDAMED number 00015561 the presented trial aims to validate an improved variant of this test including optimized LPS-depleted IE-1 protein with regard to its suitability to predict freedom from relapse of CMV-reactivation following treatment of CMV reactivation in a cohort of 120-150 patients after allo-HSCT Moreover the results will be compared to i analysis of leukocyte subpopulations and ii multimer techniques detecting CMV-specific CD8 positive T lymphocytes CTL optional
Demonstrating the suitability of the improved T-Track CMV assay to identify patients at reduced risk for recurrent CMV-reactivation CMV disease or GvHD would highly improve and optimize follow-up care after allo-HSCT regarding therapy success as well as reduced public health care costs
Since the majority of patients develops more than one episode of CMV reactivation determination of functional CMV-reactive effector cells of cell mediated immunity CMI could also help to predict the likelihood of relapsing CMV reactivations and thereby adjust the need for and duration of secondary prophylaxis
Currently available techniques to measure CMV-specific effector cells lack either a functional read out multimer stain or are time consuming and difficult to standardize detection of intracellular interferon gamma IFN-ᵞ after in vitro stimulation using flow cytometry The improved T-Track CMV assay has the advantage of combining a standardized and highly sensitive test system with a functional read out IFN-ᵞ production considering the function of antigen presenting cells APC and different populations of clinically relevant effector cells CTL T helper- NK- NKT cells Based on experiences of the performance of this assay system in healthy individuals and hemodialysis patients the latter as part of a performance evaluation - EUDAMED number 00015561 the presented trial aims to validate an improved variant of this test including optimized LPS-depleted IE-1 protein with regard to its suitability to predict freedom from relapse of CMV-reactivation following treatment of CMV reactivation in a cohort of 120-150 patients after allo-HSCT Moreover the results will be compared to i analysis of leukocyte subpopulations and ii multimer techniques detecting CMV-specific CD8 positive T lymphocytes CTL optional
Demonstrating the suitability of the improved T-Track CMV assay to identify patients at reduced risk for recurrent CMV-reactivation CMV disease or GvHD would highly improve and optimize follow-up care after allo-HSCT regarding therapy success as well as reduced public health care costs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None