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Recent advances in allogeneic hematopoietic cell transplantation (allo-SCT) have led to reduce intensity preparative regimens that are non-myeloablative and reduce the toxicities associated with the transplant. Consequently non-relapse mortality has been reduced, including in elderly patients with comorbidities. However, despite this benefit in terms of toxicity, excessive reduction of the intensity preparative regimens may favor relapse of the initial illness. Thus, acute and chronic graft-versus-host disease and opportunistic fungal and viral infections are always serious complications. The aim of our study is to check if a new modality of reduced intensity preparative regimen combining total lymphoid irradiation (TLI) and thymoglobulin (ATG), would limit the toxicity of treatment and reduce the incidence of acute GVHD after allogeneic transplantation while preserving the antitumor benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TLI and anti-thymocyte globulin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total lymphoid irradiation and anti-thymocyte globulin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the incidence of non-relapse mortality (NRM) | one year after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil and platelets recovery and chimerism measurement | To evaluate the kinetics of donor hematopoietic cell engraftment (neutrophil and platelets recovery) and chimerism. | |
| T cell subsets, regulatory cells, NK cells and B cells measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad MOHTY, Pr | Hôpital Saint Antoine (AP-HP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Besançon University Hospital | Besançon | France | ||||
| Lille University Hospital |
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|
To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, regulatory cells, NK cells and B cells.
| Number of relapse, acute and chronic GVHD | To evaluate the rate of relapse, overall and event-free survival and incidence of acute and chronic GVHD, at one year after transplantation. | one year after transplantation |
| Lille |
| France |
| Lyon University Hospital | Lyon | France |
| Nantes University Hospital | Nantes | France |
| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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