Study of How Timing of Stem Cell Infusion Affects Acute Graft-Versus-Host Disease in Patients With Nonmalignant Blood Disorders After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating how the timing of stem cell infusion affects the development of acute graft-versus-host disease aGVHD in patients with nonmalignant hematologic diseases who undergo allogeneic peripheral blood hematopoietic stem cell transplantation allo-PBSCT. This phase 3 randomized study addresses the lack of prospective data on this topic and aims to better understand the impact of infusion timing on aGVHD incidence, other transplant complications, and long-term survival. Participants are randomly assigned to receive stem cell infusions either between 1130 am and 1230 pm or between 530 pm and 630 pm. The study compares these two infusion time windows to observe differences in outcomes. This trial focuses on patients receiving allo-PBSCT for the first time and excludes those with severe organ dysfunction or other complicating factors. During the study, researchers will monitor the cumulative incidence of grade II to IV aGVHD within 100 days as the primary outcome. Secondary outcomes include the incidence of more severe aGVHD, neutrophil engraftment, platelet recovery, transplant-related mortality, chronic GVHD, and survival probabilities up to 360 days post-transplant. Participants will be closely followed for safety and effectiveness measures throughout the study period, which extends up to 360 days after transplantation.

Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases