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

Primary Purpose

Graft Versus Host Disease

Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Everolimus
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring acute GVHD, Immunosuppression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical Center, Hematology & Oncology, University of Tuebingen

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
September 6, 2006
Last Updated
May 28, 2014
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00373815
Brief Title
Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
high incidence of TTP, poor recrual
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease
Keywords
acute GVHD, Immunosuppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Everolimus
Primary Outcome Measure Information:
Title
Feasibility of oral application everolimus
Title
Daily dose needed to reach the targeted plasma level everolimus
Title
Time to reach the targeted plasma level of everolimus
Secondary Outcome Measure Information:
Title
Incidence and severity of treatment induced toxic events
Title
Incidence, severity and seriousness of adverse events
Title
Treatment induced morbidity
Title
Treatment induced 1-year-mortality
Title
Efficacy of everolimus/CSA/prednisolone on aGVHD
Title
Drug interactions between everolimus and CSA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang A Bethge, MD
Organizational Affiliation
Medical Center University of Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center, Hematology & Oncology, University of Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.onkologie-tuebingen.de
Description
Related Info

Learn more about this trial

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

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