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

University of Science and Technology of China (USTC)

Status and phase: Active, not recruiting; Phase 3

Conditions: Acute Graft-versus-host Disease

Treatments: Procedure: Time of stem cell infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06294678

infusion time & aGVHD-001

Details and patient eligibility

About

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)

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

198 participants in 2 patient groups

the early infused group

Active Comparator group

Description:

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

Treatment:

Procedure: Time of stem cell infusion

the late infused group

Sham Comparator group

Description:

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

Treatment:

Procedure: Time of stem cell infusion