To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)
Acute graft-versus-host disease (aGVHD) is a major complication and non-recurrent cause of death after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The human biological clock uses recurring environmental cues such as light and food intake to establish 24-hour rhythmic changes in sleep, hormone secretion, metabolism, body temperature, and immune function. Current clinical aGVHD prevention strategies focus on suppression of donor lymphocyte function by drugs or immunomodulatory cells, ignoring the impact of the recipient's own functional changes on the graft. The applicant's previous retrospective cohort study found that the time of stem cell infusion severely affected the incidence of aGVHD and its severity after allogeneic peripheral blood hematopoietic stem cell transplantation (allo- PBSCT). Due to the lack of prospective clinical trial results on the effect of stem cell infusion time on the occurrence of aGVHD after allo-HSCT in the international arena, as well as the possible influence of multiple confounding factors in the aforementioned single-center retrospective study, the present study intends to randomize patients according to the time of stem cell infusion, and to observe its effect on the incidence of aGVHD, other transplant-related complications, and long-term survival after allo-PBSCT of patients with nonmalignant hematologic diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
198
Randomization of patients according to the time of stem cell infusion
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
The cumulative incidence of grade II to IV aGVHD
The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. aGVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.
Time frame: 100 days
The cumulative incidence of grade III to IV aGVHD
The cumulative incidence of grade II to IV aGVHD in the first 100 days post-transplant. aGVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.
Time frame: 100 days
The cumulative incidence of neutrophil engraftment at 28 days after transplantation
neutrophil engraftment time was defined as the first of three consecutive days during which the neutrophil count was at least 0.5×10\^9/L.
Time frame: 28 days
The cumulative incidence of platelet recovery at 100 days after transplantation
Platelet recovery is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥ 100 × 10\^9/L.
Time frame: 100 days
The cumulative incidence of transplant-related mortality at 180 days after transplantation
The cumulative incidence of transplant-related mortality at 180 days after transplantation.
Time frame: 180 days
The cumulative incidence of transplant-related mortality at 360 days after transplantation
The cumulative incidence of transplant-related mortality at 360 days after transplantation.
Time frame: 1360 days
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Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGRui Jin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGThe cumulative incidence of chronic GVHD at 360 days after transplantation
The severity of chronic GVHD was graded according to the 2014 NIH criteria.
Time frame: 360 days
The probability of GVHD-free, relapse-free survival(GRFS)
The composite endpoint of GRFS was defined as the first events occurring after transplantation among Grade III to IV aGVHD, moderate to severe cGVHD, relapse, or death for any reason.
Time frame: 360 days
The probability of disease-free survival(DFS)
The DFS was defined as the interval between transplantation and disease recurrence, death or the last follow-up date, whichever occurred first.
Time frame: 360 days
The probability of overall survival(OS)
The OS was determined to be the time from the first day of transplantation until death from any cause or the last follow-up date.
Time frame: 360 days