Actively Recruiting
Led by Central Hospital, Nancy, France · Updated on 2019-10-14
700
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying donors and patients undergoing allogeneic hematopoietic stem cell transplantation to understand how different immune cell types in the graft affect immune recovery after transplant. The study aims to analyze various immune effector T cells and immunoregulatory cell subtypes, and see how these relate to important clinical outcomes like graft-versus-host disease, relapse, and infections. A related part of the research will also examine how changes in the gut microbiota affect immune responses and regulatory cells after transplant. Participants include both stem cell donors and patients receiving the transplant. The study involves collecting additional blood samples and bone marrow aspirations at multiple time points: before the graft, and then at days 0, 7, 15, 21, 30, 60, 90, 180, 1 year, and 2 years after transplant. These samples help assess the immune cell populations and stem cell graft content over time. Throughout the study, researchers will monitor the proportions of regulatory immune cells in the blood, as well as track clinical events such as graft-versus-host disease, relapse, infections, progression-free survival, and overall survival at the same time points. The study participation may last up to two years, with regular evaluations and sample collections to understand the immune recovery and clinical outcomes following transplantation.
CONDITIONS
Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years
Participants receive allogeneic hematopoietic stem cell transplantation with additional blood samples collected before graft and at multiple time points after transplantation to assess immune responses.
Approximately 11 visits for blood samples including before graft, Day 0, 7, 15, 21, 30, 60, 90, 180, 1 year, and 2 years
Duration - Up to 1 year
Participants undergo bone marrow aspiration before graft and at specified times after transplantation to evaluate immune regulation.
4 visits for bone marrow aspiration including before graft, Day 30, Day 90, and 1 year
Total: 1 location
1
CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
M
Marie-Thérèse RUBIO, PU-PH
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Anne Beatrice Notarantonio, Stéphane Morisset, Romain Piucco...
https://pubmed.ncbi.nlm.nih.gov/39905816Anne-Béatrice Notarantonio, Allan Bertrand, Romain Piucco...
https://pubmed.ncbi.nlm.nih.gov/38734654