Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease
This study has been terminated.
(high incidence of TTP, poor recrual)
Sponsor:
South West German Cancer Center
Information provided by:
South West German Cancer Center
ClinicalTrials.gov Identifier:
NCT00373815
First received: September 6, 2006
Last updated: August 18, 2010
Last verified: February 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease |
Drug: Everolimus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Sirolimus
Cyclosporine
Everolimus
Temsirolimus
U.S. FDA Resources
Further study details as provided by South West German Cancer Center:
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
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2006 |
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373815
Locations
| Germany | |
| Medical Center, Hematology & Oncology, University of Tuebingen | |
| Tuebingen, Germany, D-72076 | |
Sponsors and Collaborators
South West German Cancer Center
Investigators
| Principal Investigator: | Wolfgang A Bethge, MD | Medical Center University of Tuebingen |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00373815 History of Changes |
| Other Study ID Numbers: | 2006-002577-44 |
| Study First Received: | September 6, 2006 |
| Last Updated: | August 18, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by South West German Cancer Center:
|
acute GVHD Immunosuppression |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Cyclosporins Cyclosporine Everolimus Sirolimus Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013