NCT00373815

Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Everolimus

Timeline

• Start date: 2006-09-01
• Completion: 2009-10-01
• First posted: 2006-09-08
• Last updated: 2014-05-29

Locations

1 site across 1 country: Germany