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

NCT06294678 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: infusion time & aGVHD-001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 6

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)

Conditions

Acute Graft-versus-host Disease

Keywords

Time of stem cell infusion

Outcome Measures

Primary Outcomes (1)

• The incidence of grade II to IV aGVHD

  The primary endpoint of the study will be the development of grade II to IV aGVHD in the first 100 days post-transplant. Acute GVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.

  100 days

Secondary Outcomes (9)

• The incidence of grade III to IV aGVHD

  100 days

• The cumulative incidence of neutrophil engraftment at 28 days after transplantation

  28 days

• The cumulative incidence of platelet recovery at 100 days after transplantation

  100 days

• 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

  360 days

Study Arms (2)

the early infused group

ACTIVE COMPARATOR

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

Procedure: Time of stem cell infusion

the late infused group

SHAM COMPARATOR

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

Procedure: Time of stem cell infusion

Interventions

Time of stem cell infusion PROCEDURE

Randomization of patients according to the time of stem cell infusion

the early infused group; the late infused group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (6)

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

Hefei, Anhui, 230036, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

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

Wuhan, Hubei, 430000, China

Location

Rui Jin Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200000, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Study Officials

• Xiaoyu Zhu, ph.D

  The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: March 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)