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

NCT ID: NCT07047456

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-11

Study Completion Date

2027-12-31

Brief Summary

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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).

Detailed Description

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Acute graft-versus-host disease (aGVHD) is a major complication and cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The human circadian clock utilizes recurring environmental cues such as light exposure and food intake to establish 24-hour rhythmic variations in sleep, hormone secretion, metabolism, body temperature, and immune function. Current clinical strategies for aGVHD prevention primarily focus on pharmacological or immunomodulatory suppression of donor lymphocyte activity, often overlooking the impact of recipient physiological fluctuations on graft outcomes. Our preliminary studies revealed that the timing of stem cell infusion significantly influences the incidence and severity of aGVHD after sUCBT. Given the lack of prospective clinical trial data internationally regarding the effect of infusion timing on aGVHD development post-allo-HSCT, coupled with potential confounding factors in existing retrospective studies and pilot experiments, this study proposes to randomize patients based on umbilical cord blood infusion timing. The investigation will evaluate how infusion time affects aGVHD incidence, other transplantation-related complications, and long-term survival rates in hematologic malignancy patients undergoing sUCBT.

Conditions

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Acute Graft Versus Host Disease

Keywords

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Time of umbilical cord blood infusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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the early infused group

infused umbilical cord blood within 8 am and 9 am

Group Type ACTIVE_COMPARATOR

Time of umbilical cord blood infusion

Intervention Type PROCEDURE

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

the late infused group

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

Group Type SHAM_COMPARATOR

Time of umbilical cord blood infusion

Intervention Type PROCEDURE

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

Interventions

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Time of umbilical cord blood infusion

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoyu Zhu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of USTC

Locations

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

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyu Zhu, Ph.D

Role: CONTACT

Phone: 15255456091

Email: [email protected]

Yue Wu, Ph.D

Role: CONTACT

Phone: 13805601119

Email: [email protected]

Facility Contacts

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Xiaoyu Zhu, Ph.D

Role: primary

Yue Wu, Ph.D

Role: backup

Other Identifiers

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infusion time & UCBT

Identifier Type: -

Identifier Source: org_study_id