NCT00373815

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

First QC Date

September 6, 2006

Last Update Submit

May 28, 2014

Conditions

Graft Versus Host Disease

Keywords

acute GVHDImmunosuppression

Outcome Measures

Primary Outcomes (3)

  • 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 (6)

  • 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

  • +1 more secondary outcomes

Interventions

EverolimusDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 %

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center, Hematology & Oncology, University of Tuebingen

Tübingen, D-72076, Germany

Location

Related Links

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Wolfgang A Bethge, MD

    Medical Center University of Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

September 1, 2006

Study Completion

October 1, 2009

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

DE(1)