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

University Hospital Tuebingen

Status and phase

Terminated

Phase 1

Conditions

Graft Versus Host Disease

Treatments

Drug: Everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00373815

2006-002577-44

Details and patient eligibility

About

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.

Full 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

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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