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임상시험 NCT06294691은(는) 급성 이식편대숙주병에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases 3상 198
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임상시험 NCT06294691은(는) 예방을(를) 알아보기 위한 연구입니다. 이 연구는 급성 이식편대숙주병에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 3월 15일에 시작되어 198명의 참여자를 모집하고 있습니다. Anhui Provincial Hospital이(가) 진행하며, 2026년 8월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 6월 26일에 갱신되었습니다.
간단한 개요
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)
상세한 설명
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...더 보기
공식 제목
A Multicenter Randomized Controlled Study of the Effect of Stem Cell Infusion Time on the Development of aGVHD in Patients With Nonmalignant Hematologic Diseases After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation
질환명
급성 이식편대숙주병기타 연구 식별자
- infusion time & aGVHD-002
NCT 번호
실제 연구 시작일
2024-03-15
최신 업데이트 게시
2025-06-26
예상 연구 완료일
2026-08-31
계획된 등록 인원
198
연구종류
중재연구
단계/상
3상
상태
모집중
키워드
Time of stem cell infusion
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
활성 대조군the early infused group infused stem cell within 11:30 am and 12:30 am | Time of stem cell infusion Randomization of patients according to the time of stem cell infusion |
거짓 대조군the late infused group infused stem cell within 5:30 pm and 6:30 pm | Time of stem cell infusion Randomization of patients according to the time of stem cell infusion |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. | 100 days |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. | 100 days |
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. | 28 days |
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. | 100 days |
The cumulative incidence of transplant-related mortality at 180 days after transplantation | The cumulative incidence of transplant-related mortality at 180 days after transplantation. | 180 days |
The cumulative incidence of transplant-related mortality at 360 days after transplantation | The cumulative incidence of transplant-related mortality at 360 days after transplantation. | 1360 days |
The cumulative incidence of chronic GVHD at 360 days after transplantation | The severity of chronic GVHD was graded according to the 2014 NIH criteria. | 360 days |
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. | 360 days |
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. | 360 days |
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. | 360 days |
참여 도우미
적격성 기준
연령대
어린이, 성인
최소 연령
12 Years
참여 가능한 성별
전체
- 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.
- 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).
Anhui Provincial Hospital연구 대표 연락처
연락처: Xiaoyu Zhu, ph.D, 15255456091, [email protected]
연락처: Yue Wu, M.D, 13805601119, [email protected]
6 1개국에 임상시험 장소
Anhui
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China
Xiaoyu Zhu, ph.D, 연락처, 15255456091, [email protected]
Yue Wu, M.D, 연락처, 13805601119, [email protected]
모집중
Beijing Municipality
Peking University First Hospital, Beijing, Beijing Municipality, 100000, China
Yujun Dong, 연락처, 18210264969
모집중
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China
Weijie Cao, MD, 연락처, 15093360671
모집중
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China
Yang Cao, MD, 연락처, 13986142606, [email protected]
모집중
Shanghai Municipality
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, 200000, China
Xiaoxia Hu, Ph.D, 연락처, 13795437259, [email protected]
모집중
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Yanmin Zhao, 연락처, 15858199217, [email protected]
모집중