Evaluation of Antifungal Prophylaxis on Graft-versus-host Disease (GVHD) Patients

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Antifungal prophylaxis should be used in patients being treated with glucocorticoids for graft-versus-host disease (GVHD) following allogeneic hematopoietic stem-cell transplantation (HSCT). Although fluconazole has been widely used as an antifungal prophylactic agent after allogeneic HSCT, fluconazole prophlaxis only shows a limited protective role against IFIs, is not effective against invasive aspergillosis. In addition, NCCN guideline of the prevention and treatment of cancer-related infections recommends antifungal prophylaxis in patients with significant GVHD until resolution of GVHD using Posaconazole, Voriconazole, Echinocandin, or Amphotericin B. However, under the National Health Insurance System, none of the drug can be given prophylactically except itraconazole oral solution against IFIs. Itraconazole oral solution shows excellent bioavailability and good efficacy against aspergillus and fluconazole resistant candida infection.Based on these findings, we will perform prospective multicenter study evaluating the efficacy, safety and long-term outcomes of itraconazole oral solution prophylaxis against IFIs in patients treated with systemic corticosteroids for GVHD after allogeneic HSCT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: Janssen, LP
• Treatments: Antifungal Agents; Hydroxyitraconazole; Itraconazole; Miconazole; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients developing or developed acute or chronic GVHD within the last 10 days which require systemic immunosuppressive therapy of corticosteroids with- or-without other immunosuppressive agents including calcineurin inhibitors.

1. acute GVHD, grade 2-4

2. chronic GVHD, mild grade with high risk or moderate to severe grade

• Written informed consent form

Exclusion Criteria:

• Aspartate transaminase or alanine transaminase level > 10 times UNL or Bilirubin or alkaline phosphatase level > 5 times UNL

• Active or chronic hepatitis virus B or C infection requiring antiviral therapy

• Estimated life expectancy < 30 days

• History of allergy, sensitivity, or any serious reaction to itraconazole oral solution

• Previous history of Zygomycosis

• Evidence of active fungal disease including high galactomannan titer above 0.5, within 2 weeks.