Acute Graft-versus-host DiseasePhase 3NCT06294691
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases
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.
Trial summary
To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant 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
- 15 Mar 2024to 31 Dec 2028
- 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. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100000
Yujun Dong, 18210264969
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yanmin Zhao, 15858199217, yanminzhao@zju.edu.cn
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230036
Xiaoyu Zhu, ph.D, 15255456091, xiaoyuz@ustc.cn
Yue Wu, M.D, 13805601119, wuyue20160701@163.com
- Recruiting
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200000
Xiaoxia Hu, Ph.D, 13795437259, hu_xiaoxia@126.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yang Cao, MD, 13986142606, caoyangemma@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Weijie Cao, MD, 15093360671
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 Nonmalignant Hematologic Diseases After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation
To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)
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 nonmalignant hematologic diseases.
- 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 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 cumulative incidence of grade II to IV aGVHD
The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. aGVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.
Measured: 100 days
Secondary outcomes (9)
The cumulative incidence of grade III to IV aGVHD
The cumulative incidence of grade II 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: 1360 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.
- First posted5 Mar 2024
- Study start15 Mar 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaoyu Zhu, ph.D, Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294691
- Sponsor's protocol ID
- infusion time & aGVHD-002
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. 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 Nonmalignant Hematologic Diseases After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06294691
- Acronym / sponsor ID
- infusion time & aGVHD-002
- Conditions
- Acute Graft-versus-host Disease
- Keywords
- Time of stem cell infusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (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.
To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)
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 nonmalignant hematologic diseases.
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 cumulative incidence of grade II to IV aGVHD
Time frame: 100 days
The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. aGVHD was graded according to the Mount Sinai Acute GVHD International Consortium criteria.
9 secondary outcomes
The cumulative 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: 1360 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 24 Aug 2026.
- Individual participant dataSharing planned: No
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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.
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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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?
Contact Xiaoyu Zhu, ph.D (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative 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?
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 24 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.