NCT07047456 Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies Post UCBT
| NCT ID | NCT07047456 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Acute Graft Versus Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 134 participants in total. It began in 2025-07-11 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 single-unit unrelated cord blood transplantation (sUCBT).
Eligibility Criteria
Inclusion Criteria: * Definite diagnosis of malignant hematologic disease before transplantation, age, gender and race are not limited; * Participants were required to have achieved complete remission with negative minimal residual disease (MRD) prior to transplantation; * Participants who are proposed to receive sUCBT 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 subject's condition, if the participant'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; * Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise participant safety and put the results of the study at unnecessary risk; drug-dependent individuals; participants 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).
Contact & Investigator
Xiaoyu Zhu, Ph.D
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of University of Science and Technology of China
Frequently Asked Questions
Who can join the NCT07047456 clinical trial?
This trial is open to participants of all sexes, studying Acute Graft Versus Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07047456 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 134 participants.
Is NCT07047456 currently recruiting?
Yes, NCT07047456 is actively recruiting participants. Contact the research team at xiaoyuz@ustc.edu.cn for enrollment information.
Where is the NCT07047456 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07047456 clinical trial?
NCT07047456 is sponsored by Anhui Provincial Hospital. The principal investigator is Xiaoyu Zhu, Ph.D at The First Affiliated Hospital of University of Science and Technology of China. The trial plans to enroll 134 participants.