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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00373815
Recruitment Status : Terminated (high incidence of TTP, poor recrual)
First Posted : September 8, 2006
Last Update Posted : May 29, 2014
Sponsor:
Information provided by:
University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE September 6, 2006
First Posted Date  ICMJE September 8, 2006
Last Update Posted Date May 29, 2014
Study Start Date  ICMJE September 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • Feasibility of oral application everolimus
  • Daily dose needed to reach the targeted plasma level everolimus
  • Time to reach the targeted plasma level of everolimus
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Graft Versus Host Disease
Intervention  ICMJE Drug: Everolimus
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September 6, 2006)
10
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373815
Other Study ID Numbers  ICMJE 2006-002577-44
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wolfgang A Bethge, MD Medical Center University of Tuebingen
PRS Account University Hospital Tuebingen
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP