ClinicalTrials.gg
RecruitingNCT06294691Updated Aug 24, 2026

Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases

A Phase 3 interventional study of Time of stem cell infusion in Acute Graft-versus-host Disease, sponsored by Anhui Provincial Hospital. Recruiting at 6 sites in China. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Anhui Provincial Hospital · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.

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Phase
Phase 3
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
12 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 81 studies in Graft vs Host Disease with a site in China — 38 open to participants now, 43 under way, 8 of them phase 3. Graft vs Host Disease · China.

Planned enrollment
10th of 72
198 · median 53
Started
2024
with 10 others
Phase 3
12 of 81
7 open now
Primary completion
2027-12
later than 28 of 42 live
Registered
47th of 81
by date
Lead sponsor
4 of 81
Anhui Provincial Hospital

Among the 81 studies in Graft vs Host Disease with a site in China, this one is the 10th largest by planned enrollment of the 72 interventional ones that give a count, is one of 11 that started in 2024, is one of 12 in phase 3, reaches primary completion later than 28 of the 42 other live ones, and was the 47th registered.

Graft vs Host Disease

804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.

Browse Graft vs Host Disease studies →

Open to participants now

38 of the 81 studies in Graft vs Host Disease with a site in China are open now. Recruiting first, the newest first:

33 more — sign in →

All 38 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 103 Graft vs Host Disease studies recruiting now, 51 (50%) set no upper age limit and 42 (41%) stop at 75 or younger; 42 take children under 18; 9 take healthy volunteers.

This study: 12 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Acute Graft-versus-host Disease

Browse trials for

Keywords

  • Time of stem cell infusion
04

Who can participate

Ages eligible
12 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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;
  • (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 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
198 participants (estimated)

Study arms

  • Active comparator
    the early infused group

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

    Procedure: Time of stem cell infusion

  • Sham comparator
    the late infused group

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

    Procedure: Time of stem cell infusion

Interventions

  • ProcedureTime of stem cell infusion

    Randomization of patients according to the time of stem cell infusion

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 100 days

Secondary outcomes

  1. 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.

    Time frame: 100 days

  2. 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.

    Time frame: 28 days

  3. 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.

    Time frame: 100 days

  4. The cumulative incidence of transplant-related mortality at 180 days after transplantation

    The cumulative incidence of transplant-related mortality at 180 days after transplantation.

    Time frame: 180 days

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

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

    Time frame: 1360 days

  6. The cumulative incidence of chronic GVHD at 360 days after transplantation

    The severity of chronic GVHD was graded according to the 2014 NIH criteria.

    Time frame: 360 days

  7. 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.

    Time frame: 360 days

  8. 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.

    Time frame: 360 days

  9. 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.

    Time frame: 360 days

07

Study locations

6 of 6 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Dec 2027, 45 months after the start.

Of 31 phase 3 interventional studies under Graft vs Host Disease, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 48. This study's planned 45 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2024
First posted
Mar 5, 2024
StartActual
Mar 15, 2024
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06294691
Responsible party
Sponsor
First posted
Mar 5, 2024
Start date
Mar 15, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 24, 2026

Study contacts

Xiaoyu Zhu, ph.D
Contact
xiaoyuz@ustc.edu.cn
15255456091
Yue Wu, M.D
Contact
wuyue20160701@163.com
13805601119
Xiaoyu Zhu, ph.D
principal investigator · The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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