Prospective Analysis of an individualized dosing Regimen of ATG (Thymoglobulin) in Children Undergoing HCT: redUcing Toxicity and improving Efficacy * a single arm phase II study - Parachute trial

niversitair Medisch Centrum Utrecht0 个研究点目标入组 53 人开始时间: 待定最近更新: 2024年6月11日

试验速览

暂无简介。

•* All patients eligible for a non-haplo-identical non-T-cell depleted HCT with Thymoglobulin as part of the conditioning regimen treated in the pediatric ward of the UMCU Utrecht or the LUMC Leiden
•* Any stem cell source
•* First transplantation
•* Age at time of transplantation < 18 years
•* Signed written informed consent according to local law and regulations
•* Lansky/Karnofsky * 80%

•* Withdrawal of or no informed consent
•* No Thymoglobuline in conditioning regimen
•* Lansky / Karnofsky <80%
•* Ex-vivo T-cell depleted grafts
•* Other serotherapy in conditioning (e.g. campath, or campath in the bag)
•* Received serotherapy within 3 months before this transplantation
•* Pregnancy
•* Sensibility to rabbit proteins or previous treatment with Thymoglobulin
•* Acute or chronic infections, in which each form of immune suppression is contra-indicated
•* Patients not receiving the full intentioned dose of Thymoglobulin due to any reason
•* Cardiac ejection fraction < 30%
•* No complete remission (CR-status) in case of malignancy
•* History of serious immune-mediated reactions or hypersensitivity to any biological product
•* Participation in other trial in which the dose of Thymoglobulin is fixed to amounts other than the individualized dose.

发起方

niversitair Medisch Centrum Utrecht