Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT07047456
Brief Summary:
To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with malignant hematologic diseases after single-unit unrelated cord blood transplantation (sUCBT).
Detailed Description:
Acute graft-versus-host disease (aGVHD) is a major complication and cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The human circadian clock utilizes recurring environmental cues such as light exposure and food intake to establish 24-hour rhythmic variations in sleep, hormone secretion, metabolism, body temperature, and immune function. Current clinical strategies for aGVHD prevention primarily focus on pharmacological or immunomodulatory suppression of donor lymphocyte activity, often overlooking the impact of recipient physiological fluctuations on graft outcomes. Our preliminary studies revealed that the timing of stem cell infusion significantly influences the incidence and severity of aGVHD after sUCBT. Given the lack of prospective clinical trial data internationally regarding the effect of infusion timing on aGVHD development post-allo-HSCT, coupled with potential confounding factors in existing retrospective studies and pilot experiments, this study proposes to randomize patients based on umbilical cord blood infusion timing. The investigation will evaluate how infusion time affects aGVHD incidence, other transplantation-related complications, and long-term survival rates in hematologic malignancy patients undergoing sUCBT.
Study:
NCT07047456
Study Brief:
Protocol Section:
NCT07047456