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治験 NCT06294691（対象：急性移植片対宿主病）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases 第III相・フェーズ3 198
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治験番号 NCT06294691 は 急性移植片対宿主病 に関する 予防 の研究で、第III相・フェーズ3 介入研究 臨床試験 です。現在は 募集中 で、2024年3月15日 から開始しています。198 名の参加者 の募集が計画されています。この試験は Anhui Provincial Hospital によって主導され、2026年8月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年6月26日 です。
概要
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)
詳細説明
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...もっと見る
公式タイトル
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
疾患名
急性移植片対宿主病その他の研究識別子
- infusion time & aGVHD-002
NCT番号
開始日
2024-03-15
最終更新日
2025-06-26
終了予定日
2026-08-31
目標参加者数
198
試験の種類
介入研究
治験の相・段階
第III相・フェーズ3
状況
募集中
キーワード
Time of stem cell infusion
主目的
予防
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬the 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 |
シャム対照薬the 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 |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
小児, 成人
試験の最低年齢
12 Years
対象性別
全て
- 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 Hospital試験中央連絡先
連絡先: Xiaoyu Zhu, ph.D, 15255456091, [email protected]
連絡先: Yue Wu, M.D, 13805601119, [email protected]
6 1カ国の場所
Anhui
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China
Xiaoyu Zhu, ph.D, 連絡先, 15255456091, [email protected]
Yue Wu, M.D, 連絡先, 13805601119, [email protected]
募集中
Beijing Municipality
Peking University First Hospital, Beijing, Beijing Municipality, 100000, China
Yujun Dong, 連絡先, 18210264969
募集中
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China
Weijie Cao, MD, 連絡先, 15093360671
募集中
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China
Yang Cao, MD, 連絡先, 13986142606, [email protected]
募集中
Shanghai Municipality
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, 200000, China
Xiaoxia Hu, Ph.D, 連絡先, 13795437259, [email protected]
募集中
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Yanmin Zhao, 連絡先, 15858199217, [email protected]
募集中