NCT06294691 Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases
| NCT ID | NCT06294691 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Acute Graft-versus-host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2025-11-30 |
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 198 participants in total. It began in 2024-03-15 with a primary completion date of 2025-11-30.
⚠ 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 nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)
Eligibility Criteria
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).
Contact & Investigator
Xiaoyu Zhu, ph.D
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Frequently Asked Questions
Who can join the NCT06294691 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 60 Years, 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 NCT06294691 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 198 participants.
Is NCT06294691 currently recruiting?
Yes, NCT06294691 is actively recruiting participants. Contact the research team at xiaoyuz@ustc.edu.cn for enrollment information.
Where is the NCT06294691 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Zhengzhou, China, Wuhan, China and 2 additional locations.
Who is sponsoring the NCT06294691 clinical trial?
NCT06294691 is sponsored by Anhui Provincial Hospital. The principal investigator is Xiaoyu Zhu, ph.D at The First Affiliated Hospital of USTC (Anhui Provincial Hospital). The trial plans to enroll 198 participants.