Acute Graft-versus-host DiseasePhase 3NCT06294678

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

A Phase 3 study testing Time of stem cell infusion in people with Acute Graft-versus-host Disease, run by Anhui Provincial Hospital at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 12 to 60 years
Conditions the study is for: Acute Graft-versus-host Disease
What is being tested?: Time of stem cell infusion
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 198 participants
Where: 6 sitesChina
Study dates: 1 Mar 2024to 31 Aug 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Peking University First Hospital
Beijing, Beijing Municipality, 100000
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230036
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200000
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Multicenter Randomized Controlled Study of the Effect of Stem Cell Infusion Time on the Development of aGVHD in Patients With Hematological Malignancies After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation

Read the detailed 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.

Conditions: Acute Graft-versus-host Disease
Being tested: Time of stem cell infusion
Keywords: Time of stem cell infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Time of stem cell infusionProcedure or surgery
Randomization of patients according to the time of stem cell infusion

Study groups in NCT06294678
Study group	Role	What they receive
the early infused group	Active comparator	infused stem cell within 11:30 am and 12:30 am Receives: Procedure: Time of stem cell infusion
the late infused group	Sham comparator	infused stem cell within 5:30 pm and 6:30 pm Receives: Procedure: Time of stem cell infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 100 days

Secondary outcomes (9)

The incidence of grade III to IV aGVHD
The cumulative incidence of grade III to IV aGVHD in the first 100 days post-transplant. aGVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.
Measured: 100 days
The cumulative incidence of neutrophil engraftment at 28 days after transplantation
neutrophil engraftment time was defined as the first of three consecutive days during which the neutrophil count was at least 0.5×10^9/L.
Measured: 28 days
The cumulative incidence of platelet recovery at 100 days after transplantation
Platelet recovery is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥ 100 × 10^9/L.
Measured: 100 days
The cumulative incidence of transplant-related mortality at 180 days after transplantation
The cumulative incidence of transplant-related mortality at 180 days after transplantation
Measured: 180 days
The cumulative incidence of transplant-related mortality at 360 days after transplantation
The cumulative incidence of transplant-related mortality at 360 days after transplantation
Measured: 360 days
The cumulative incidence of chronic GVHD at 360 days after transplantation
The severity of chronic GVHD was graded according to the 2014 NIH criteria.
Measured: 360 days
The probability of GVHD-free, relapse-free survival(GRFS)
The composite endpoint of GRFS was defined as the first events occurring after transplantation among Grade III to IV aGVHD, moderate to severe cGVHD, relapse, or death for any reason.
Measured: 360 days
The probability of disease-free survival(DFS)
The DFS was defined as the interval between transplantation and disease recurrence, death or the last follow-up date, whichever occurred first.
Measured: 360 days
The probability of overall survival(OS)
The OS was determined to be the time from the first day of transplantation until death from any cause or the last follow-up date.
Measured: 360 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202431 Aug 2026

First posted5 Mar 2024
Study start1 Mar 2024
Primary completion30 Sep 2025
Study completion31 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Graft-versus-host DiseaseStudies of the same condition, open and under way.
More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06294678
Sponsor's protocol ID: infusion time & aGVHD-001
Status last verified: Dec 2025
First submitted: 28 Feb 2024
Last updated: 31 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Randomized Controlled Study of the Effect of Stem Cell Infusion Time on the Development of aGVHD in Patients With Hematological Malignancies After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT06294678
Acronym / sponsor ID: infusion time & aGVHD-001
Conditions: Acute Graft-versus-host Disease
Keywords: Time of stem cell infusion
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 198 participants (actual)
Lead sponsor: Anhui Provincial HospitalOther government
Study start: 1 Mar 2024 (actual)
Primary completion: 30 Sep 2025 (actual)
Study completion: 31 Aug 2026 (estimated)
First posted: 5 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
the early infused group	Active comparator	Procedure: Time of stem cell infusioninfused stem cell within 11:30 am and 12:30 am
the late infused group	Sham comparator	Procedure: Time of stem cell infusioninfused stem cell within 5:30 pm and 6:30 pm

Who may qualify

Ages: 12 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Time of stem cell infusionRandomization of patients according to the time of stem cell infusion	Procedure or surgery	the early infused group, the late infused group

Primary outcome

The incidence of grade II to IV aGVHD
Time frame: 100 days
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.

9 secondary outcomes

The incidence of grade III to IV aGVHD
Time frame: 100 days
The cumulative incidence of neutrophil engraftment at 28 days after transplantation
Time frame: 28 days
The cumulative incidence of platelet recovery at 100 days after transplantation
Time frame: 100 days
The cumulative incidence of transplant-related mortality at 180 days after transplantation
Time frame: 180 days
The cumulative incidence of transplant-related mortality at 360 days after transplantation
Time frame: 360 days
The cumulative incidence of chronic GVHD at 360 days after transplantation
Time frame: 360 days
The probability of GVHD-free, relapse-free survival(GRFS)
Time frame: 360 days
The probability of disease-free survival(DFS)
Time frame: 360 days
The probability of overall survival(OS)
Time frame: 360 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
Individual participant dataSharing planned: No

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RecruitingObservational study
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Pyelonephritis
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Acute Ischemic Stroke
Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaoyu Zhu, ph.D principal investigator

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

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Time of stem cell infusion in people with Acute Graft-versus-host Disease, run by Anhui Provincial Hospital at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of grade II to IV aGVHD (time frame: 100 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06294678.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.