Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies
Status:
Completed
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
Summary
The primary goal of this study is to evaluate an alternative myeloablative, but reduced
toxicity conditioning regimen in children, to describe the safety and efficacy of intravenous
(i.v.) Treosulfan administered as part of a standardised Fludarabine-containing conditioning
and to contribute to the current pharmacokinetic model to be able to finally give age (or
body surface area) dependent dose recommendations. The treatment regimens given in the
protocol MC-FludT.17/M are based on sufficient clinical safety and efficacy data. Considering
the vital indication for allogeneic haematopoietic stem cell transplantation of the selected
patient population, the risk-benefit assessment is therefore reasonably in favour of the
study conduct.