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

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sirolimus

Criteria

Inclusion Criteria:

• Written informed consent prior to inclusion into the study

• Allogeneic HSCT from HLA-identical related or unrelated donors

• Clinically confirmed acute GVHD ≥ grade II

• Age < 70 / > 18 years, male or female

• Karnofsky performance status > 60 %

Exclusion Criteria:

• Oral treatment is not feasible

• Severe hepatic impairment Child-Pugh C

• Active cerebral epilepsy

• Renal failure (Creatinine clearance < 50 ml/min)

• Life expectancy < 3 months

• Known hypersensitivity to everolimus, sirolimus or to any of the excipients

• Confirmed pregnancy (serum β-HCG)

• Non-effective contraception for both, male and female patients, if the risk of conception exists

• Patients with limited legal capacity

• Patients unwilling and unable to undergo study procedures