Timing is everything: new study tests if stem cell infusion time prevents transplant complications
NCT ID NCT06294678
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether the time when stem cells are given to blood cancer patients after a donor transplant affects their risk of developing acute graft-versus-host disease (aGVHD), a serious complication where donor cells attack the patient's body. About 198 patients aged 12-60 will be randomly assigned to receive their stem cell infusion at different times. The main goal is to see if timing can lower the chance of moderate to severe aGVHD in the first 100 days after transplant.
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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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198 people
The number who actually took part.
- Started
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Mar 2024
- Expected to finish
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Aug 2026
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.
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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.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100000, China
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Rui Jin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200000, China
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230036, China
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children
- Can a new drug stop the Body's attack after stem cell transplants?
- Could a simple timing change make stem cell transplants safer?