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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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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

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Graft Versus Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Everolimus

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No