NCT01282879

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

January 23, 2011

Last Update Submit

January 24, 2011

Conditions

Graft vs Host Disease

Keywords

Itraconazole oral solutioninvasive fungal infectionsprophylaxisGraft vs Host Diseasetransplantation

Outcome Measures

Primary Outcomes (1)

  • incidence of proven or probable invasive fungal infections

    at day 100 after starting graft-versus-host disease (GVHD) treatment with corticosteroids based regimen in adjunction to itraconazole oral solution antifungal prophylaxis.

Secondary Outcomes (2)

  • safety profiles of itraconazole oral solution

    during GVHD treatment with corticosteroids containing regimen

  • GVHD-specific survival (GSS) of patients receiving corticosteroids based GVHD treatment together with antifungal prophylaxis with itraconazole oral solution

    from the onset of acute or chronic GVHD to death due to GVHD itself or GVHD-related complications

Study Arms (1)

itraconazole, prophylaxis, Oral solution

EXPERIMENTAL

For GVHD patients who are required systemic glucocorticoids therapy, itraconazole oral solution will be administered at a dose of 200mg every 12 hours.

Drug: Itraconazole

Interventions

ItraconazoleDRUG

200mg bid, oral solution, until a dose of prednisone was tapered to 10mg/day in case of prednisone alone therapy group, or until prednisone was stopped in case of CNIs plus prednisone, CNIs plus prednisone plus mycophenolate mofetil, or mycophenolate mofetil plus prednisone group, etc.

Also known as: Sporanox oral solution
itraconazole, prophylaxis, Oral solution

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • acute GVHD, grade 2-4
  • chronic GVHD, mild grade with high risk or moderate to severe grade
  • Written informed consent form

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Inje University Pusan Paik Hospital

Busan, Busan, South Korea

Location

Gachon University Gil Hospital

Incheon, Incheon, South Korea

Location

Inha University Hospital

Incheon, Incheon, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, Kyounggi-do, South Korea

Location

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

Chung-ang University Hospital

Seoul, Seoul, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

Soonchunhyang University Seoul Hospital

Seoul, Seoul, South Korea

Location

Related Publications (3)

  • Walsh TJ, Anaissie EJ, Denning DW, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Segal BH, Steinbach WJ, Stevens DA, van Burik JA, Wingard JR, Patterson TF; Infectious Diseases Society of America. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008 Feb 1;46(3):327-60. doi: 10.1086/525258. No abstract available.

    PMID: 18177225BACKGROUND

  • Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.

    PMID: 1542320RESULT

  • Winston DJ, Maziarz RT, Chandrasekar PH, Lazarus HM, Goldman M, Blumer JL, Leitz GJ, Territo MC. Intravenous and oral itraconazole versus intravenous and oral fluconazole for long-term antifungal prophylaxis in allogeneic hematopoietic stem-cell transplant recipients. A multicenter, randomized trial. Ann Intern Med. 2003 May 6;138(9):705-13. doi: 10.7326/0003-4819-138-9-200305060-00006.

    PMID: 12729424RESULT

MeSH Terms

Conditions

Graft vs Host DiseaseInvasive Fungal Infections

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Immune System DiseasesMycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Dong Hwan Kim, M.D./Ph.D.

    Division of Hematology/Oncology, Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2011

First Posted

January 25, 2011

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 25, 2011

Record last verified: 2011-01

Locations

KR(9)