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

A Phase I Dose Escalation Study With Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00373815

Enrollment

Registered

2006-09-08

Start date

2006-09-30

Completion date

2009-10-31

Last updated

2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease

Keywords

acute GVHD, Immunosuppression

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

Interventions

DRUGEverolimus

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026