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

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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:

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.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Drug: Everolimus Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2006
Study Completion Date : October 2009


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Feasibility of oral application everolimus
  2. Daily dose needed to reach the targeted plasma level everolimus
  3. Time to reach the targeted plasma level of everolimus

Secondary Outcome Measures :
  1. Incidence and severity of treatment induced toxic events
  2. Incidence, severity and seriousness of adverse events
  3. Treatment induced morbidity
  4. Treatment induced 1-year-mortality
  5. Efficacy of everolimus/CSA/prednisolone on aGVHD
  6. Drug interactions between everolimus and CSA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373815


Locations
Germany
Medical Center, Hematology & Oncology, University of Tuebingen
Tuebingen, Germany, D-72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Wolfgang A Bethge, MD Medical Center University of Tuebingen
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00373815     History of Changes
Other Study ID Numbers: 2006-002577-44
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by University Hospital Tuebingen:
acute GVHD
Immunosuppression

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Everolimus
Sirolimus
Prednisolone
Methylprednisolone Hemisuccinate
Cyclosporins
Cyclosporine
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists