Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.
Malignant hematologic disorders;
Patients undergoing UCBT;
Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year.
Non-malignant hematologic disorders;
History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
Uncontrolled bacterial, viral, or fungal infections. "Uncontrolled" is defined as lack of clinical improvement or progression despite adequate antimicrobial therapy;
HIV infection or active hepatitis B or C virus infection;
Single group
Basiliximab
DrugAddition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical cord blood transplantation (UCBT)
The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)
The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. Acute GVHD was graded according to the International Consortium criteria.
The incidence rate and occurrence time of pre-engraftment syndrome (PES)
The occurrence time and cumulative incidence of PES within 30 days post-UCBT. The PES was diagnosed according to the criteria of engraftment syndrome (ES) .
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 engraftment at 100 days after transplantation
Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥ 20 × 10\^9/L.
The incidence of grade II 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 aGVHD International Consortium criteria.
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