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

NCT07047456 | Recruiting Phase 3 DMC

• 1 other identifier: infusion time & UCBT
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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 single-unit unrelated cord blood transplantation (sUCBT).

Conditions

Acute Graft Versus Host Disease

Keywords

Time of umbilical cord blood infusion

Outcome Measures

Primary Outcomes (1)

• The incidence of grade III to IV aGVHD

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

  100 days post transplantation

Secondary Outcomes (9)

• The incidence of grade II to IV aGVHD

  100 days post transplantation

• The cumulative incidence of neutrophil engraftment at 42 days after transplantation

  42 days post transplantation

• The cumulative incidence of platelet engraftment at 60 days after transplantation

  60 days post transplantation

• The cumulative incidence of transplant-related mortality at 360 days after transplantation

  360 days post transplantation

• The cumulative incidence of relapse at 360 days after transplantation

  360 days post transplantation

Study Arms (2)

the early infused group

ACTIVE COMPARATOR

infused umbilical cord blood within 8 am and 9 am

Procedure: Time of umbilical cord blood infusion

the late infused group

SHAM COMPARATOR

infused umbilical cord blood within 11:30 am and 12:30 pm

Procedure: Time of umbilical cord blood infusion

Interventions

Time of umbilical cord blood infusion PROCEDURE

Randomization of patients according to the time of umbilical cord blood infusion

the early infused group; the late infused group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite diagnosis of malignant hematologic disease before transplantation, age, gender and race are not limited;
• Participants were required to have achieved complete remission with negative minimal residual disease (MRD) prior to transplantation;
• Participants who are proposed to receive sUCBT 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 subject's condition, if the participant'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;
• Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise participant safety and put the results of the study at unnecessary risk; drug-dependent individuals; participants 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 (1)

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

Hefei, Anhui, 230001, China

RECRUITING

Study Officials

• Xiaoyu Zhu, Ph.D

  The First Affiliated Hospital of USTC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Zhu, Ph.D

CONTACT

15255456091; xiaoyuz@ustc.edu.cn

Yue Wu, Ph.D

CONTACT

13805601119; ayxswy@mail.ustc.edu.cn

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: June 23, 2025
• First Posted: July 2, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)