Factors Affecting Immune Response After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Central Hospital, Nancy, France · Updated on 2019-10-14
700
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
Research Team
M
Marie-Thérèse RUBIO, PU-PH
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Patient of the Nancy CHRU scheduled for an allogeneic hematopoietic stem cell transplant
Hematopoietic stem cell donors receiving care at Nancy CHRU during the research period
Age 18 years or older
You will not qualify if you...
Positive HIV test
Active hepatitis B infection
Active hepatitis C infection
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
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
Treatment
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Differential Clinical and Immunological Impacts of Anti-T-Lymphocyte Globulin (ATLG) vs. Anti-Thymocyte Globulin (ATG) in Preventing Graft-Versus-Host Disease Post-Allogeneic Hematopoietic Stem Cell Transplantation: A Comparative Study.
Anne Beatrice Notarantonio, Stéphane Morisset, Romain Piucco...