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.

eiden University Medical Center0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年6月11日

试验速览

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•diagnosis of severe congenital immune deficiency or of congenital hematological disorder with indication for allogeneic stem cell transplantation (HSCT)
•age at diagnosis and at the time of HSCT = 18 years
•Alemtuzumab treatment intravenously is given as part of a treosulfan- or a busulfan-based reduced intensity conditioning regimen prior to HSCT
•all donor types and hematopoietic stem cell sources will be considered
•HSCT 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 HSCT per patient, further transplantations will only be considered if a minimal serotherapy-free interval of 3 months is preceding the second transplant

•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
•active malignancy
•pregnancy/lactation

发起方

eiden University Medical Center