רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT06294691 עבור מחלת שתל נגד מאכסן חריפה הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases שלב III 198
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT06294691 מתקיים כדי לבדוק את מניעה עבור מחלת שתל נגד מאכסן חריפה. זהו מחקר שלב III מסוג התערבותי שנמצא כעת במצב מגייס. המחקר התחיל ב-15 במרץ 2024 ומתוכנן לכלול 198 משתתפים. המחקר מנוהל על ידי Anhui Provincial Hospital וצפוי להסתיים ב-31 באוגוסט 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-26 ביוני 2025.
סיכום קצר
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)
תיאור מפורט
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...הצג עוד
כותרת רשמית
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
מצבים רפואיים
מחלת שתל נגד מאכסן חריפהמזהי מחקר נוספים
- infusion time & aGVHD-002
מספר NCT
תחילת המחקר (בפועל)
2024-03-15
עדכון אחרון שפורסם
2025-06-26
סיום המחקר (מוערך)
2026-08-31
משתתפים (מתוכנן)
198
סוג המחקר
התערבותי
שלב
שלב III
סטטוס
מגייס
מילות מפתח
Time of stem cell infusion
מטרה ראשית
מניעה
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
משווה פעילthe 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 |
מדומה להשוואהthe 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 |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
ילד, מבוגר
גיל מינימלי למחקר
12 Years
מגדרים מוערכים למחקר
הכל
- 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 Hospitalאיש קשר מרכזי למחקר
איש קשר: Xiaoyu Zhu, ph.D, 15255456091, [email protected]
איש קשר: Yue Wu, M.D, 13805601119, [email protected]
6 מיקומי המחקר ב-1 מדינות
Anhui
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China
Xiaoyu Zhu, ph.D, איש קשר, 15255456091, [email protected]
Yue Wu, M.D, איש קשר, 13805601119, [email protected]
מגייס
Beijing Municipality
Peking University First Hospital, Beijing, Beijing Municipality, 100000, China
Yujun Dong, איש קשר, 18210264969
מגייס
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China
Weijie Cao, MD, איש קשר, 15093360671
מגייס
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China
Yang Cao, MD, איש קשר, 13986142606, [email protected]
מגייס
Shanghai Municipality
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, 200000, China
Xiaoxia Hu, Ph.D, איש קשר, 13795437259, [email protected]
מגייס
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Yanmin Zhao, איש קשר, 15858199217, [email protected]
מגייס