NCT07047456

Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies Post UCBT

Prospective Randomized Controlled Phase III Clinical Study on the Impact of Stem Cell Infusion Timing on the Incidence of Acute Graft-versus-host Disease in Patients With Hematologic Malignancies Following Single-unit Umbilical Cord Blood Transplantation

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Graft Versus Host Disease

Interventions

Type	Name	Description
PROCEDURE	Time of umbilical cord blood infusion	Randomization of patients according to the time of umbilical cord blood infusion

Timeline

• Start date: 2025-07-11
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-07-02
• Last updated: 2025-12-23

Locations

1 site across 1 country: China