Description for experts
The aim of the study is to explore the safety and feasibility of a Treg-based approach as an adjunct immunosuppressive treatment for HSCT recipients early after HSCT. The goal is to prevent the development of acute GvHD, to moderate the severity and to reduce the need for pharmacologic immunosuppression, most specifically the exposure towards steroids, and thus the immunosuppressive burden after HSCT, which exposes recipients to relevant morbidity and potentially
mortality.
Description for laymen
The aim of the study is to investigate the safety and feasibility of a Treg-based approach as a complementary immunosuppressive treatment for HSCT recipients early after HSCT. The aim is to prevent the development of acute GvHD, mitigate its severity and reduce the need for pharmacologic immunosuppression, in particular steroid exposure.
JSON Data
{
"short_title": "Atreg-001",
"data_mode": "900",
"data_mode_number": "000002313",
"official_title": "Safety, Tolerability and Feasibility of Treatment with GP120-activated Regulatory T cells (ATreg) Early After Haematopoietic Stem Cell Transplantation (HSCT) to Reduce the Incidence and Severity of Acute Graft vs Host Disease (GvHD) ",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "kurativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "not_applicable",
"ctgov_number": null,
"eudract_number": "2021-006490-32",
"general_contact_email": "ectu@ukdd.de",
"general_contact_phone": "+49 351-4587566",
"hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke",
"description_laie_de": "Ziel der Studie ist es, die Sicherheit und Durchf\u00fchrbarkeit eines Treg-basierten Ansatzes als erg\u00e4nzende immunsuppressive Behandlung f\u00fcr HSCT Empf\u00e4ngern fr\u00fch nach der HSCT zu untersuchen. Ziel ist es, die Entwicklung einer akuten GvHD zu verhindern, den Schweregrad zu mildern und den Bedarf an pharmakologischen Immunsuppression, insbesondere der Steroidexposition Steroide, zu verringern.",
"description_laie_en": "The aim of the study is to investigate the safety and feasibility of a Treg-based approach as a complementary immunosuppressive treatment for HSCT recipients early after HSCT. The aim is to prevent the development of acute GvHD, mitigate its severity and reduce the need for pharmacologic immunosuppression, in particular steroid exposure.",
"description_expert_de": "Ziel der Studie ist es, die Sicherheit und Durchf\u00fchrbarkeit eines Treg-basierten Ansatzes als erg\u00e4nzende immunsuppressive Behandlung f\u00fcr HSCT Empf\u00e4ngern fr\u00fch nach der HSCT zu untersuchen. Ziel ist es, die Entwicklung einer akuten GvHD zu verhindern, den Schweregrad zu mildern und den Bedarf an pharmakologischen Immunsuppression, insbesondere der Steroidexposition Steroide, zu verringern.",
"description_expert_en": "The aim of the study is to explore the safety and feasibility of a Treg-based approach as an adjunct immunosuppressive treatment for HSCT recipients early after HSCT. The goal is to prevent the development of acute GvHD, to moderate the severity and to reduce the need for pharmacologic immunosuppression, most specifically the exposure towards steroids, and thus the immunosuppressive burden after HSCT, which exposes recipients to relevant morbidity and potentially \r\nmortality.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I_II",
"main_cat_id": 4,
"sub_cat_id": 30
}
