NL-OMON55607已完成不适用
Impact of Alemtuzumab exposure on immune reconstitution, autoimmunity, risk of infection, chimerism and Graft-versus-Host Disease in children with non-malignant diseases undergoing allogeneic stem cell transplantation. ARTIC International Multicenter Observational Study. - ARTIC study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •diagnosis of severe congenital immune deficiency or of congenital
- •hematological disorder with an indication for HSCT, e.g. (severe) combined
- •immunodeficiency ((S)CID), hemophagocytic lymphohistiocytosis (HLH), chronic
- •granulomatous disease (CGD), thalassemia major, sickle cell disease (SCD);
- •age at diagnosis and at the time of HSCT <= 18 years;
- •Alemtuzumab treatment intravenously (iv) is given as part of a treosulfan- or
- •a busulfan-based reduced intensity conditioning regimen prior to alloHSCT;
- •all donor types and hematopoietic stem cell sources will be considered;
- •allogeneic hematopoietic stem cell transplantation is performed in a study
- •participating center; written consent of the parents (legal guardian) and of
- •the patient herself or himself if >=14 years old (>=12 years old in the
- •Netherlands);
- •in case of multiple alloHSCT per patient, further transplantations will only
- •be considered if a minimal serotherapy-free interval of 3 months is preceding
- •the second transplant
排除标准
- •patients who do not fulfill the inclusion criteria;
- •patients with known hypersensitivity to Alemtuzumab;
- •patients treated with other serotherapy drugs (e.g. anti-thymocyte globulin -
- •ATG) within the same conditioning regimen prior to HSCT;
- •patients who received any other serotherapy in the last 3 months before
- •starting this observational study;
- •known HIV-positivity;
- •severe uncontrolled infections before alloHSCT;
- •active malignancies;
- •pregnancy/lactation.
研究者
相似试验
招募中
不适用
Impact of alemtuzumab exposure on immune reconstitution, autoimmunity, risk of infection, chimerism and graft-versus-host disease in children with non-malignant diseases undergoing allogeneic stem celltransplantation - an International Multicenter Observational Study.NL-OMON22218eiden University Medical Center30
招募中
不适用
Cellular immunity after alemtuzumabMultiple sclerosisG35DRKS00011205niversitätsklinikum Köln20
已完成
2 期
Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampathAdult Acute Lymphocytic Leukemia T-cellLymphoma, LymphoblasticNCT00199030Goethe University8
已完成
2 期
Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation PatientsLiver TransplantationLiver DiseaseNCT00105235National Institute of Allergy and Infectious Diseases (NIAID)27
已完成
2 期
Alemtuzumab to Treat Severe Aplastic AnemiaSevere Aplastic Anemia, RefractorySevere Aplastic Anemia, RelapseNCT00195624National Heart, Lung, and Blood Institute (NHLBI)47