Actively Recruiting
Effect of Stem Cell Infusion Time on Acute Graft-versus-Host Disease Development in Patients with Nonmalignant Hematologic Diseases After Allogeneic Peripheral Blood Stem Cell Transplantation
Led by Anhui Provincial Hospital · Updated on 2025-06-26
198
Participants Needed
6
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
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 11:30 am and 12:30 pm or between 5:30 pm and 6:30 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.
CONDITIONS
Brief Title
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Definite diagnosis of malignant hematologic disease before transplantation
- Age between 12 and 60 years
- Gender is not limited
- Patients proposed to receive allo-PBSCT for the first time
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- No serious organ failure or active infection
- Willing to participate in an open randomized controlled study
- Signed informed consent form or legal representative consent
You will not qualify if you...
- Severe organ dysfunction or disease such as heart, liver, kidney, or pancreas failure
- Pregnancy
- Refusal to participate in an open randomized controlled study
- Life-threatening diseases, drug dependency, uncontrolled psychiatric disorders, or cognitive dysfunction
- Participation in other clinical studies affecting aGVHD within 3 months
- Considered unsuitable by investigator due to inability to adhere to study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion procedure on the day of transplantation
Participants receive stem cell infusion at a randomized time to evaluate its effect on acute graft-versus-host disease after allogeneic peripheral blood stem cell transplantation.
1 infusion visit (in-person)
Duration - Up to 360 days after transplantation
Participants are monitored for the development of acute and chronic graft-versus-host disease, transplant-related complications, and survival.
Regular visits for assessments up to 1 year
Trial Site Locations
Total: 6 locations
1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230036
Actively Recruiting
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Actively Recruiting
4
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
5
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
6
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiaoyu Zhu, ph.D
Y
Yue Wu, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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