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

Phase 1TerminatedNCT00373815

University Hospital Tuebingen10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Graft Versus Host Disease

Interventions

EverolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Center, Hematology & Oncology, University of Tuebingen

Tübingen, Germany

Outcomes

Primary Outcomes

Feasibility of oral application everolimus

Daily dose needed to reach the targeted plasma level everolimus

Time to reach the targeted plasma level of everolimus

Secondary Outcomes

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

Data from ClinicalTrials.gov

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