An interventional study of Blood Sample and Bone marrow aspiration in Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Central Hospital, Nancy, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-14.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other
The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.
Exclusion Criteria:
Biological: Blood Sample · Biological: Bone marrow aspiration
Biological: Blood sample · Biological: Allogeneic hematopoietic stem cell sample
Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2
Additional bone marrow aspiration before graft, D30, D90, Y1
Before donation
Allogeneic hematopoietic stem cell sample
Proportions of regulatory immune cells in peripheral blood.
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Occurrence of graft versus host (GVH) reaction after allografting of CSH
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of relapse
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of infections
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Progress-free survival
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Overall survival
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Plan to share: No
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Central Hospital, Nancy, France