An observational study in ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Diabetes Mellitus and Impaired Fasting Glucose, sponsored by Ruijin Hospital. Not yet recruiting at 6 sites in China. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by Ruijin Hospital · Observational
To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important means of treating a variety of hematologic disorders. With the progress of HSCT technology, especially the research on haploidentical transplantation (HID-HSCT), the range of donor choices for hematological patients has been expanded, and theoretically, the era of "everyone has a donor" has been reached, which has increased the chances for hematological patients to receive allo-HSCT . The efficacy of allo-HSCT has improved dramatically over the past decades, but post-transplant complications such as graft-versus-host disease (GvHD), infections, and disease recurrence may still lead to treatment failure. In order to improve the efficacy of allo-HSCT, in addition to the improvement of pretreatment regimen and post-transplant management, the selection of the best donor among the many alternatives (including sibling donors, parents, children, and collateral hematologic donors, etc.) is still the focus and difficulty of clinical decision-making. The existing studies on donor selection have suggested that the factors to be considered include the number of HLA mismatched sites, donor-recipient consanguinity, donor age and gender, donor-specific antibody (DSA), NK cell isotype reactivity, and clonal hematopoiesis of the donor . However, little is known about whether a donor with metabolic syndrome such as diabetes affects post-transplant survival in allo-HSCT recipients.
It has been shown that diabetes mellitus affects the number and function of hematopoietic and immune cells, and that these effects may be passed on to progeny blood cells through epigenetic mechanisms, with long-term effects on immune cell function in diabetic patients. We therefore hypothesized that the effects of abnormal glucose metabolism in donors on the hematopoietic system may affect hematopoiesis and immune reconstitution in transplant recipients through "metabolic memory". Therefore, the investigator conduct a multicenter retrospective study through multifactorial survival regression. It is expected to provide new theoretical support for optimizing donor selection for allo-HSCT.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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Patients who were diagnosed with hematological disorders and underwent allo-HSCT
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Laboratory results within 7 days prior to HSCT met the following criteria:
Exclusion Criteria:
patients who underwent allogeneic hematopoietic stem cell transplantation from March 2019 to March 2024; donor fasting blood glucose and/or HbA1c data available; fasting blood glucose ≥6.1 mmol/L or HbA1c ≥5.7%
patients who underwent allogeneic hematopoietic stem cell transplantation from March 2019 to March 2024; donor fasting blood glucose and/or HbA1c data available; fasting blood glucose \<6.1 mmol/L; HbA1c \<5.7% (if available)
Overall Survival (OS)
Patient's overall survival time since hematopoietic stem cell transplantation
Time frame: One year-overall survival since hematopoietic stem cell transplantation
Non-relapse Mortality (NRM)
NRM after hematopoietic stem cell transplantation
Time frame: One year since hematopoietic stem cell transplantation
Relapse-free Survival (RFS)
RFS after hematopoietic stem cell transplantation
Time frame: One year since hematopoietic stem cell transplantation
Event-free Survival (EFS)
EFS after hematopoietic stem cell transplantation
Time frame: One year since hematopoietic stem cell transplantation
Graft versus Host Disease (GvHD) incidence
GvHD incidence after hematopoietic stem cell transplantation
Time frame: One year since hematopoietic stem cell transplantation
GvHD and Relapse-free Survival (GRFS)
GRFS incidence after hematopoietic stem cell transplantation
Time frame: One year since hematopoietic stem cell transplantation
Cumulative Incidence Rate (CIR)
CIR after hematopoietic stem cell transplantation
Time frame: One year since hematopoietic stem cell transplantation
Graft Time of Different Cell Subpopulation
Graft Time of Platelet, Neutrophil
Time frame: One year since hematopoietic stem cell transplantation
Plan to share: No
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Start is estimated for Nov 2024; primary completion for Apr 2025, 5 months later.
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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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