About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited;
Patients who are proposed to receive allo-PBSCT for the first time;
Eastern Cooperative Oncology Group (ECOG) score 0-2;
No serious organ failure and active infection;
Disqualifiers
Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
Pregnant patients;
Patients and/or authorized family members who refuse to undergo an open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;
Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at unnecessary risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction;
Trial design
Parallel
Treatments tested in this trial
Time of stem cell infusion
Procedure/SurgeryRandomization of patients according to the time of stem cell infusion
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
The cumulative incidence of transplant-related mortality at 180 days after transplantation
The cumulative incidence of transplant-related mortality at 180 days after transplantation.
Sponsors and contacts
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