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 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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of oral application everolimus
Wolfgang A Bethge, MD
Principal Investigator
Medical Center University of Tuebingen
Germany: Federal Institute for Drugs and Medical Devices
2006-002577-44
NCT00373815
September 2006
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