Graft Versus Host Disease Clinical Trial
Official title:
A Phase I Dose Escalation Study With Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus.
The primary objective of the present study is to evaluate the feasibility of treatment with
everolimus in combination with CSA/prednisolone in patients with aGVHD after allogeneic
HSCT. This evaluation takes into account the following parameters:
- Feasibility of oral application everolimus
- Daily dose needed to reach the targeted plasma level everolimus
- Time to reach the targeted plasma level of everolimusSecondary objectivesThe study will
evaluate the toxicity and safety of the treatment with ever-olimus/CSA/prednisolone
with regard to
- Incidence and severity of treatment induced toxic events
- Incidence, severity and seriousness of adverse events
- Treatment induced morbidity
- Treatment induced 1-year-mortality Furthermore the study will collect data about
- Efficacy of everolimus/CSA/prednisolone on aGVHD
- Drug interactions between everolimus and CSA
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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