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O estudo clínico NCT06294691 para Doença do enxerto contra o hospedeiro aguda está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases Fase III 198
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06294691 procura avaliar prevenção para Doença do enxerto contra o hospedeiro aguda. Este é um estudo intervencionista de Fase III. Seu status atual é: em recrutamento. O estudo começou em 15 de março de 2024 e pretende incluir 198 participantes. Coordenado por Anhui Provincial Hospital e deve ser concluído em 31 de agosto de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 26 de junho de 2025.
Resumo
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)
Descrição detalhada
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...Mostrar mais
Título oficial
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
Condições médicas
Doença do enxerto contra o hospedeiro agudaOutros IDs do estudo
- infusion time & aGVHD-002
Número NCT
Data de início (real)
2024-03-15
Última atualização postada
2025-06-26
Data de conclusão (estimada)
2026-08-31
Inscrição (estimada)
198
Tipo de estudo
Intervencionista
FASE
Fase III
Status
Em recrutamento
Palavras-chave
Time of stem cell infusion
Propósito principal
Prevenção
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Comparador ativothe 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 |
Comparador simuladothe 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 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto
Idade mínima
12 Years
Sexos elegíveis
Todos
- 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 HospitalContato central do estudo
Contato: Xiaoyu Zhu, ph.D, 15255456091, [email protected]
Contato: Yue Wu, M.D, 13805601119, [email protected]
6 Locais do estudo em 1 países
Anhui
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China
Xiaoyu Zhu, ph.D, Contato, 15255456091, [email protected]
Yue Wu, M.D, Contato, 13805601119, [email protected]
Em recrutamento
Beijing Municipality
Peking University First Hospital, Beijing, Beijing Municipality, 100000, China
Yujun Dong, Contato, 18210264969
Em recrutamento
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China
Weijie Cao, MD, Contato, 15093360671
Em recrutamento
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China
Yang Cao, MD, Contato, 13986142606, [email protected]
Em recrutamento
Shanghai Municipality
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, 200000, China
Xiaoxia Hu, Ph.D, Contato, 13795437259, [email protected]
Em recrutamento
Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China
Yanmin Zhao, Contato, 15858199217, [email protected]
Em recrutamento