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

Last updated: June 23, 2025
Sponsor: Anhui Provincial Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Hematologic Neoplasms

Treatment

Time of stem cell infusion

Clinical Study ID

NCT06294678
infusion time & aGVHD-001
  • Ages 12-60
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 cellinfusion affects the occurrence of aGVHD after transplantation;

  • Each subject must sign an informed consent form (ICF) indicating that he/sheunderstands the purpose and procedures of the study and is willing to participate inthe study; in view of the patient's condition, if the patient's own signature is notconducive to the treatment of his/her condition, the ICF will be signed by the legalrepresentative.

Exclusion

Exclusion Criteria:

  • Those with severe organ dysfunction or disease, such as severe disease anddysfunction of the heart, liver, kidneys and pancreas;

  • Pregnant patients;

  • Patients and/or authorized family members who refuse to undergo an open randomizedcontrolled study to observe whether the time of stem cell infusion affects theoccurrence 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 theresults of the study at unnecessary risk; drug-dependent individuals; patients withuncontrolled 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 whoanticipate that patients will not be able to adhere to the examination and treatmentdue to financial and other issues).

Study Design

Total Participants: 198
Treatment Group(s): 1
Primary Treatment: Time of stem cell infusion
Phase: 3
Study Start date:
March 01, 2024
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

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

    Hefei, Anhui 230036
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

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

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • Rui Jin Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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