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Clinical Trial NCT06294691 for Acute Graft-versus-host Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases Phase 3 198

Recruiting
Clinical Trial NCT06294691 is designed to study Prevention for Acute Graft-versus-host Disease. It is a Phase 3 interventional study that is recruiting, having started on 15 March 2024, with plans to enroll 198 participants. Led by Anhui Provincial Hospital, it is expected to complete by 31 August 2026. The latest data from ClinicalTrials.gov was last updated on 26 June 2025.
Brief Summary
To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)
Detailed Description
Acute graft-versus-host disease (aGVHD) is a major complication and non-recurrent cause of death after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The human biological clock uses recurring environmental cues such as light and food intake to establish 24-hour rhythmic changes in sleep, hormone secretion, metabolism, body temperature, and immune function. Current clinical aGVHD prevention strategies...Show More
Official Title

A Multicenter Randomized Controlled Study of the Effect of Stem Cell Infusion Time on the Development of aGVHD in Patients With Nonmalignant Hematologic Diseases After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation

Conditions
Acute Graft-versus-host Disease
Other Study IDs
  • infusion time & aGVHD-002
NCT ID Number
NCT06294691
Start Date (Actual)
2024-03-15
Last Update Posted
2025-06-26
Completion Date (Estimated)
2026-08-31
Enrollment (Estimated)
198
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
Time of stem cell infusion
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active Comparatorthe early infused group
infused stem cell within 11:30 am and 12:30 am
Time of stem cell infusion
Randomization of patients according to the time of stem cell infusion
Sham Comparatorthe late infused group
infused stem cell within 5:30 pm and 6:30 pm
Time of stem cell infusion
Randomization of patients according to the time of stem cell infusion
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The cumulative incidence of grade II to IV aGVHD
The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. aGVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.
100 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The cumulative incidence of grade III 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 Mount Sinai Acute GVHD International Consortium criteria.
100 days
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.
28 days
The cumulative incidence of platelet recovery at 100 days after transplantation
Platelet recovery is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥ 100 × 10\^9/L.
100 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 transplant-related mortality at 360 days after transplantation
The cumulative incidence of transplant-related mortality at 360 days after transplantation.
1360 days
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 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.
360 days
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.
360 days
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.
360 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
12 Years
Eligible Sexes
All
  • Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited;
  • Patients who are proposed to receive allo-PBSCT for the first time;
  • Eastern Cooperative Oncology Group (ECOG) score 0-2;
  • No serious organ failure and active infection;
  • Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;
  • Each subject must sign an informed consent form (ICF) indicating that he/ she understands the purpose and procedures of the study and is willing to participate in the study; in view of the patient's condition, if the patient's own signature is not conducive to the treatment of his/her condition, the ICF will be signed by the legal representative.

  • Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
  • Pregnant patients;
  • Patients and/or authorized family members who refuse to undergo an open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;
  • Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at unnecessary risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction;
  • Participants in other clinical studies that may affect aGVHD within 3 months;
  • Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).
Anhui Provincial Hospital logoAnhui Provincial Hospital
Study Central Contact
Contact: Xiaoyu Zhu, ph.D, 15255456091, [email protected]
Contact: Yue Wu, M.D, 13805601119, [email protected]
6 Study Locations in 1 Countries

Anhui

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China
Xiaoyu Zhu, ph.D, Contact, 15255456091, [email protected]
Yue Wu, M.D, Contact, 13805601119, [email protected]
Recruiting

Beijing Municipality

Peking University First Hospital, Beijing, Beijing Municipality, 100000, China
Yujun Dong, Contact, 18210264969
Recruiting

Henan

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China
Weijie Cao, MD, Contact, 15093360671
Recruiting

Hubei

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China
Yang Cao, MD, Contact, 13986142606, [email protected]
Recruiting

Shanghai Municipality

Rui Jin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, 200000, China
Xiaoxia Hu, Ph.D, Contact, 13795437259, [email protected]
Recruiting

Zhejiang

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Yanmin Zhao, Contact, 15858199217, [email protected]
Recruiting