Everolimus in Combination With Cyclosporine A and Prednis... | NCT00373815

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

NCT00373815

Sponsor

University Hospital Tuebingen

Status

Terminated

Last Update Posted

May 29, 2014Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Graft Versus Host Disease

Interventions

Everolimus

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

high incidence of TTP, poor recrual

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Oct 2009Actual

First Submitted Date

Sep 6, 2006

First Submission Date that Met QC Criteria

Sep 6, 2006

First Posted Date

Sep 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2014

Last Update Posted Date

May 29, 2014Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
Incidence and severity of treatment induced toxic events
Incidence, severity and seriousness of adverse events
Treatment induced morbidity

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolfgang A Bethge, MD	Medical Center University of Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center, Hematology & Oncology, University of Tuebingen		Tübingen		D-72076	Germany

Label	URL
Related Info	View source

ID	Term
D006086	Graft vs Host Disease

ID	Term
D007154	Immune System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000068338	Everolimus

Ancestor Terms

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided