An observational study in Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation and Graft Vs Host Disease, sponsored by Affiliated Hospital to Academy of Military Medical Sciences. Completed at 1 site in China. Open to participants aged 12 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-10-04.
Sponsored by Affiliated Hospital to Academy of Military Medical Sciences · Observational
Graft-versus-Host Disease (GVHD) and relapse, which is mainly due to lack of Graft-versus-Leukemia (GVL), are the most frequent and severe complications of allogeneic hematopoietic stem cell transplantation (allo-HSCT). T cells expanded from mature T cells in the graft play a dominant role in development of GVHD and GVL early after allo-HSCT. Recent applications of high-throughput sequencing (HTS) to the T cells repertoire open a new avenue for us to look deeply into how these T cells dynamically adjust in the context of the recipient's environment.
The main goal of this research study is to set up a mathematical model based on T cell receptor (TCR) sequencing to enable prediction for the key immunologic outcomes early post-transplantation. This study will deepen the understanding of the molecular mechanisms driving the most deadly post-transplantation complications, and serve as convincing evidence upon which to choose a better donor and a more proper transplantation approach.
This observational trial will perform HTS for TCR β-chain complementarity determining region 3 (CDR3) repertoires of grafts and peripheral blood samples from recipients post-transplantation and analyze the relationship between dynamics of TCR CDR3 repertoires and clinical outcomes early post-transplantation, especially including GVHD and relapse. The investigators want to know how the antigen environment in recipients drives dynamics of mature T cells from grafts in order to use the new discovered rules to better predict and treat the disease process.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 30 is below the median of 186 across 326 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Affiliated Hospital to Academy of Military Medical Sciences is the lead sponsor of 65 studies on the registry; 9 are open to participants now.
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Patients undergone myeloablative hematopoietic stem cell transplantation about 1 year ago.
Exclusion Criteria:
Myeloablative hematopoietic stem cell transplantation from many kinds of donors, including matched related donor, matched unrelated donor, haploidentical related donor.
Perform TCR β-chain CDR3 high-throughput sequencing and TCR repertoire analysis on T cells from the graft and the peripheral blood at the time of 1-month, 2-month after allo-HSCT.
To identify the mechanisms specific for TCR repertoire dynamics and rearrangement characteristics.
Time frame: 3 months
Perform longitudinal immune analysis on T cells purified from patients undergoing allogeneic HSCT who develop acute and chronic GVHD, relapse, and virus infectious complications post-transplant.
Characterize the main TCR β-chain CDR3 sequences dynamic change responsible for acute GVHD, chronic GVHD and defects in protective immunity in patients undergoing HSCT.
Time frame: 1 year
Perform horizontal comparison analysis on the diversity index of T cells purified from the grafts and the patients undergoing allogeneic HSCT.
Characterize the TCR β-chain CDR3 repertoire dynamic change responsible for acute GVHD, chronic GVHD and defects in protective immunity in patients undergoing HSCT.
Time frame: 1 year
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Affiliated Hospital to Academy of Military Medical Sciences