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

Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00373815
• Other study ID #: 2006-002577-44
• Status: Terminated
• Phase: Phase 1
• First received: September 6, 2006
• Last updated: May 28, 2014
• Start date: September 2006
• Est. completion date: October 2009

Study information

• Verified date: May 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ß-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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Everolimus

Locations

Country	Name	City	State
Germany	Medical Center, Hematology & Oncology, University of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of oral application everolimus
Primary	Daily dose needed to reach the targeted plasma level everolimus
Primary	Time to reach the targeted plasma level of everolimus
Secondary	Incidence and severity of treatment induced toxic events
Secondary	Incidence, severity and seriousness of adverse events
Secondary	Treatment induced morbidity
Secondary	Treatment induced 1-year-mortality
Secondary	Efficacy of everolimus/CSA/prednisolone on aGVHD
Secondary	Drug interactions between everolimus and CSA

External Links

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