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

NCT ID: NCT06294678

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-08-31

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 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 focus on suppression of donor lymphocyte function by drugs or immunomodulatory cells, ignoring the impact of the recipient's own functional changes on the graft. The applicant's previous retrospective cohort study found that the time of stem cell infusion severely affected the incidence of aGVHD and its severity after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT). Due to the lack of prospective clinical trial results on the effect of stem cell infusion time on the occurrence of aGVHD after allo-HSCT in the international arena, as well as the possible influence of multiple confounding factors in the aforementioned single-center retrospective study, the present study intends to randomize patients according to the time of stem cell infusion, and to observe its effect on the incidence of aGVHD, other transplant-related complications, and long-term survival after allo-PBSCT of patients with hematological malignancies.

Conditions

Acute Graft-versus-host Disease

Keywords

Time of stem cell infusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

the early infused group

infused stem cell within 11:30 am and 12:30 am

Group Type: ACTIVE_COMPARATOR

Time of stem cell infusion

Intervention Type: PROCEDURE

Randomization of patients according to the time of stem cell infusion

the late infused group

infused stem cell within 5:30 pm and 6:30 pm

Group Type: SHAM_COMPARATOR

Time of stem cell infusion

Intervention Type: PROCEDURE

Randomization of patients according to the time of stem cell infusion

Interventions

Time of stem cell infusion

Randomization of patients according to the time of stem cell infusion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyu Zhu, ph.D

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Locations

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Rui Jin Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

infusion time & aGVHD-001

Identifier Type: -

Identifier Source: org_study_id