Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635397
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2020-11-06
Brief Title:
Immunomonitoring After Hematopoietic Stem Cell Transplantation
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Immunomonitoring After Hematopoietic Stem Cell Transplantation for Hematological Malignancies Using Cytokines Profiling and Flow Cytometry
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
Allo Monitor
Brief Summary:
Allogeneic hematopoietic stem cell transplantation HSCT remains the only curative option for many hematologic malignancies in particular acute leukemias and myelodysplastic syndromes
At the center of these reactions are the donors T and NK cells Several studies have highlighted the impact of T cells reconstitution on post-transplant infection rates relapse and GvHD
Most of the post-allogeneic immune reconstitution studies available to us today include young patients 60 years of age who have had genoidentic or phenoidentic 1010 allografts and mostly only study the phenotype of a limited number of immune cells While it is important to know the absolute number reconstitution kinetics of the different categories of immune cells it is essential to also be able to assess the function of the different cells Knowledge of the restoration of T function at key dates after allogeneic stem cell transplantation would make it possible to adapt post allogeneic immunomodulation immunosuppressive treatment and injections of donor lymphocytes and anti-infectious prophylaxis for patients The measurement of cytokine profiles after nonspecific stimulation of T and NK lymphocytes recently made available to the immunology laboratory of the CHU de Nice allows a routine assessment of T lymphocyte function Th1 Th2 Th 17 and T regulatory and NK by measurement of the secretion of different cytokines after stimulation of the patients lymphocytes with different antigens anti-CD3 and anti-TLR7
The cytokine profile during immune reconstitution in hematopoietic cell transplants has never been evaluated we will analyze it with regard to clinical data relapse infections and GVHD
At the center of these reactions are the donors T and NK cells Several studies have highlighted the impact of T cells reconstitution on post-transplant infection rates relapse and GvHD
Most of the post-allogeneic immune reconstitution studies available to us today include young patients 60 years of age who have had genoidentic or phenoidentic 1010 allografts and mostly only study the phenotype of a limited number of immune cells While it is important to know the absolute number reconstitution kinetics of the different categories of immune cells it is essential to also be able to assess the function of the different cells Knowledge of the restoration of T function at key dates after allogeneic stem cell transplantation would make it possible to adapt post allogeneic immunomodulation immunosuppressive treatment and injections of donor lymphocytes and anti-infectious prophylaxis for patients The measurement of cytokine profiles after nonspecific stimulation of T and NK lymphocytes recently made available to the immunology laboratory of the CHU de Nice allows a routine assessment of T lymphocyte function Th1 Th2 Th 17 and T regulatory and NK by measurement of the secretion of different cytokines after stimulation of the patients lymphocytes with different antigens anti-CD3 and anti-TLR7
The cytokine profile during immune reconstitution in hematopoietic cell transplants has never been evaluated we will analyze it with regard to clinical data relapse infections and GVHD
Detailed Description:
Allogeneic hematopoietic stem cell transplantation HSCT remains the only curative option for many hematologic malignancies in particular acute leukemias and myelodysplastic syndromes
The success of the allogeneic transplant is based on the Graft versus Leukemia GvL effect which corresponds to the elimination of tumor cells by the donors immune system from the recipients body Conversely graft versus host disease GvHD is an immune response of the donor versus the host due to major and or minor histocompatibility differences resulting in multi-organ damage and being the main cause of transplant-related mortality The main causes of death in allogeneic patients are infections relapse of the initial disease and GvHD The relapse linked to an ineffectiveness of the anti-tumor response of the donors immune system is responsible for 40 of transplant failures GvHD is present in 40 to 70 of transplants In both cases therapeutic options are available in order to modulate the immune response
In fact in the event of a relapse of the disease reinjections of donor lymphocytes make it possible to trigger a GvL effect and cure For patients with GvHD on the other hand treatment is based on increased immunosuppression
At the center of these reactions are the donors T and NK cells Several studies have highlighted the impact of T immune reconstitution on post-transplant infection rates relapse and GvHD
Infections and relapses may be linked to insufficient antiviral or anti-tumor responses of the graft Th1 pathway deficiency while GvHD is linked to an excessive response of the graft against the host cells Immune imbalance associating a excess of Th1 Th2 and Th17 responses
However there is currently no routine test to predict the kinetics and quality of immune reconstitution in allogeneic patients
Most of the post-allogeneic immune reconstitution studies available to us today include young patients 60 years of age who have had genoidentic or phenoidentic 1010 allografts and mostly only study the phenotype of a limited number of immune cells While it is important to know the absolute number reconstitution kinetics of the different categories of immune cells it is essential to also be able to assess the function of the different cells
The evaluation of lymphocyte function is mainly based on the measurement of their ability to secrete different cytokines This measure currently requires complex procedures exclusively reserved for research Knowledge of the restoration of T function at key dates after allogeneic stem cell transplantation would make it possible to adapt post allogeneic immunomodulation immunosuppressive treatment and injections of donor lymphocytes and anti-infectious prophylaxis for patients The measurement of cytokine profiles after nonspecific stimulation of T and NK lymphocytes recently made available to the immunology laboratory of the CHU de Nice allows a routine assessment of T lymphocyte function Th1 Th2 Th 17 and T regulatory and NK by measurement of the secretion of different cytokines after stimulation of the patients lymphocytes with different antigens anti-CD3 and anti-TLR7
The immunology laboratory of the Nice University Hospital recently demonstrated in a cohort of patients with a kidney transplant that the level of secretion of INF-γ Th1 pathway by T lymphocytes after non-specific stimulation was correlated with the risk of rejection and inversely correlated with the risk of infectious complications In addition in a cohort of patients with an autoimmune disease Extra-Membranous Glomerulonephritis the level of secretion of pro-inflammatory cytokines from the Th17 pathway IL6 IL17 etc was correlated with the risk of thrombo-complications embolic and relapse
The cytokine profile during immune reconstitution in hematopoietic cell transplants has never been evaluated we will analyze it with regard to clinical data relapse infections and GVHD
The success of the allogeneic transplant is based on the Graft versus Leukemia GvL effect which corresponds to the elimination of tumor cells by the donors immune system from the recipients body Conversely graft versus host disease GvHD is an immune response of the donor versus the host due to major and or minor histocompatibility differences resulting in multi-organ damage and being the main cause of transplant-related mortality The main causes of death in allogeneic patients are infections relapse of the initial disease and GvHD The relapse linked to an ineffectiveness of the anti-tumor response of the donors immune system is responsible for 40 of transplant failures GvHD is present in 40 to 70 of transplants In both cases therapeutic options are available in order to modulate the immune response
In fact in the event of a relapse of the disease reinjections of donor lymphocytes make it possible to trigger a GvL effect and cure For patients with GvHD on the other hand treatment is based on increased immunosuppression
At the center of these reactions are the donors T and NK cells Several studies have highlighted the impact of T immune reconstitution on post-transplant infection rates relapse and GvHD
Infections and relapses may be linked to insufficient antiviral or anti-tumor responses of the graft Th1 pathway deficiency while GvHD is linked to an excessive response of the graft against the host cells Immune imbalance associating a excess of Th1 Th2 and Th17 responses
However there is currently no routine test to predict the kinetics and quality of immune reconstitution in allogeneic patients
Most of the post-allogeneic immune reconstitution studies available to us today include young patients 60 years of age who have had genoidentic or phenoidentic 1010 allografts and mostly only study the phenotype of a limited number of immune cells While it is important to know the absolute number reconstitution kinetics of the different categories of immune cells it is essential to also be able to assess the function of the different cells
The evaluation of lymphocyte function is mainly based on the measurement of their ability to secrete different cytokines This measure currently requires complex procedures exclusively reserved for research Knowledge of the restoration of T function at key dates after allogeneic stem cell transplantation would make it possible to adapt post allogeneic immunomodulation immunosuppressive treatment and injections of donor lymphocytes and anti-infectious prophylaxis for patients The measurement of cytokine profiles after nonspecific stimulation of T and NK lymphocytes recently made available to the immunology laboratory of the CHU de Nice allows a routine assessment of T lymphocyte function Th1 Th2 Th 17 and T regulatory and NK by measurement of the secretion of different cytokines after stimulation of the patients lymphocytes with different antigens anti-CD3 and anti-TLR7
The immunology laboratory of the Nice University Hospital recently demonstrated in a cohort of patients with a kidney transplant that the level of secretion of INF-γ Th1 pathway by T lymphocytes after non-specific stimulation was correlated with the risk of rejection and inversely correlated with the risk of infectious complications In addition in a cohort of patients with an autoimmune disease Extra-Membranous Glomerulonephritis the level of secretion of pro-inflammatory cytokines from the Th17 pathway IL6 IL17 etc was correlated with the risk of thrombo-complications embolic and relapse
The cytokine profile during immune reconstitution in hematopoietic cell transplants has never been evaluated we will analyze it with regard to clinical data relapse infections and GVHD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A02138-31 | OTHER | ID RCB | None |