Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases
NCT Number: NCT06480630
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Graft Versus Host Disease|Malignant Hematologic Neoplasm
Interventions: DRUG: Basiliximab
Sponsor: Anhui Provincial Hospital
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 39
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2027-06-30
Locations: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, China

Summary:
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.

Primary Outcome Measures: 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., within 100 days post-UCBT
Secondary Outcome Measures: 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) ., within 30 days post-UCBT|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., within 28 days post-UCBT|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., within 100 days post-UCBT|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., within 100 days post-UCBT|The cumulative incidence of chronic GVHD at 360 days after transplantation, The severity of chronic GVHD was graded according to the 2014 NIH criteria., 360 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., 180 days|The cumulative incidence of relapse, The cumulative incidence of relapse at 1 year after transplantation., 1 year|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., 1 year|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., 1 year|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., 1 year