Could a simple timing change make stem cell transplants safer?
NCT ID NCT06294691
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial tests whether the time at which stem cells are infused after a transplant affects the risk of acute graft-versus-host disease (aGVHD), a serious complication where donor cells attack the patient's body. It involves 198 patients with nonmalignant blood diseases receiving their first allogeneic peripheral blood stem cell transplant. Participants are randomly assigned to different infusion times, and researchers track the development of aGVHD in the first 100 days after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Timing of stem cell infusion (procedure)
- What this could lead to
- If timing matters, this could lower the risk of severe graft-versus-host disease after stem cell transplants, making the procedure safer for patients with nonmalignant blood disorders.
- What could go wrong
- This is a phase 3 trial, but the effect of timing is uncertain and may not reduce aGVHD. Risks include transplant complications and the possibility that timing has no impact.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 198 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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; * 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. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, 100000, China
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Rui Jin Hospital Affiliated to Shanghai Jiao Tong University
RECRUITINGShanghai, Shanghai Municipality, 200000, China
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
RECRUITINGHefei, Anhui, 230036, China
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The First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, Henan, 450000, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a lung protein tame severe graft-versus-host disease?
- Combination drug approach aims to tame immune attack after stem cell transplant
- New shot may shield transplant patients from deadly immune attack
- New drug shows promise in controlling transplant complications
- Poop pills may tame deadly transplant complication
- JAKAVI under the microscope: new study tracks GVHD treatment in real life