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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


Phase 1
18 Years
70 Years
Not Enrolling
Both
Graft Versus Host Disease

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of oral application everolimus

Principal Investigator

Wolfgang A Bethge, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Center University of Tuebingen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

2006-002577-44

NCT ID:

NCT00373815

Start Date:

September 2006

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • acute GVHD
  • Immunosuppression
  • Graft vs Host Disease

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