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

Phase 1

Terminated

• Conditions: Graft Versus Host Disease

• Registration Number: NCT00373815
• Lead Sponsor: University Hospital Tuebingen

Brief 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

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-06
• Study First Posted: 2006-09-08
• Study Completion: 2009-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Daily dose needed to reach the targeted plasma level everolimus
Time to reach the targeted plasma level of everolimus
Feasibility of oral application everolimus

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of treatment induced toxic events
Incidence, severity and seriousness of adverse events
Treatment induced morbidity
Treatment induced 1-year-mortality
Efficacy of everolimus/CSA/prednisolone on aGVHD
Drug interactions between everolimus and CSA

Trial Locations

Locations (1)

Medical Center, Hematology & Oncology, University of Tuebingen; 🇩🇪 Tuebingen, Germany