This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).

Condition	Treatment or Intervention	Phase
Mycoses	Drug: Posaconazole oral suspension	Phase III

Further Study Details: 

Expected Total Enrollment:  600

This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis of IFI in high-risk subjects with Grade II-IV acute graft vs. host disease (GVHD) or extensive chronic GVHD. The primary objective is to assess the efficacy of SCH56592 vs fluconazole in preventing proven or probable IFI within the time period from randomization to 16 weeks after the start of treatment with study drug.

Ages Eligible for Study:  13 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Hematopoietic progenitor cell transplant subjects with chronic or Grade II-IV acute GVHD being treated with high dose immunosuppressive therapy.
• One of the following to the subject's prior immunosuppressive regimen: (a) at least 1mg per kg per day of methylprednisolone or equivalent, (b) Antithymocyte globulin (ATG) for the therapy of acute GVHD, (c) Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.

Arkansas
      University of AR for Med. Sciences, Little Rock,  Arkansas,  United States
California
      City of Hope National Medical Center, Duarte,  California,  91010,  United States
      St. Joseph Hospital, Orange,  California,  92868-5600,  United States
      Orange County Children's Hospital, Orange,  California,  92868,  United States
Colorado
      University of Colorado-HSC, Denver,  Colorado,  80262,  United States
      Blood and Marrow Transplant Program - RMCC, Denver,  Colorado,  80218,  United States
Connecticut
      Univ. of Connecticut Health Center, Farmington,  Connecticut,  06030,  United States
      Yale University School of Medicine, New Haven,  Connecticut,  06520-8032,  United States
Delaware
      Christiana Health Care Health Services, Newark,  Delaware,  19718,  United States
Florida
      University of Florida, Gainesville,  Florida,  32610-0277,  United States
      Walt Disney Memorial Cancer Institute, Orlando,  Florida,  32804,  United States
      Univ. of South Florida, Tampa,  Florida,  United States
      Nemours Children's Clinic, Jacksonville,  Florida,  32207,  United States
Georgia
      Emory University BMT Center, Atlanta,  Georgia,  30322,  United States
      BMT Group of Georgia, Atlanta,  Georgia,  30342,  United States
Illinois
      Loyola University, Maywood,  Illinois,  60153,  United States
      Rush Presbyterian St. Luke's Medical Center, Chicago,  Illinois,  60612-3813,  United States
Indiana
      Indiana Blood and Marrow Transplantation, Beech Grove,  Indiana,  46107,  United States
Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160,  United States
Kentucky
      Brown Cancer Center, Louisville,  Kentucky,  40202-3229,  United States
Louisiana
      Louisiana State University Medical Center, Shreveport,  Louisiana,  71130,  United States
Maryland
      Johns Hopkins Hospital Oncology Center, Baltimore,  Maryland,  21231,  United States
      University of Maryland School of Medicine, Baltimore,  Maryland,  21201-1595,  United States
Massachusetts
      Mass General Hospital, Boston,  Massachusetts,  02114,  United States
      Umass Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
      New England Medical Center, Boston,  Massachusetts,  02111,  United States
Michigan
      Harper Hospital, Detroit,  Michigan,  48201,  United States
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
Minnesota
      University of Minnesota Medical Center, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Kansas City Cancer Center, Kansas City,  Missouri,  64111,  United States
      Washington University, St. Louis,  Missouri,  631110-1093,  United States
Nebraska
      University of Nebraska, Omaha,  Nebraska,  68198-7680,  United States
New Jersey
      Hackensack Univ. Medical Center, Hackensack,  New Jersey,  07601,  United States
New York
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
North Carolina
      Duke Medical Center, Durham,  North Carolina,  United States
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106-5089,  United States
      Jewish Hospital, Cincinnati,  Ohio,  45236,  United States
Oklahoma
      Univ. of Oklahoma Dept of Medicine, Oklahoma City,  Oklahoma,  73104,  United States
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201,  United States
Pennsylvania
      University of Penn Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
      The Western Pennsylvania Hospital BMT Program, Pittsburgh,  Pennsylvania,  15224-1791,  United States
      Jeanes Hospital of TUHS, Philadelphia,  Pennsylvania,  19111,  United States
South Carolina
      University of South Carolina, Columbia,  South Carolina,  29203,  United States
Texas
      Methodist Hospital, Houston,  Texas,  77030,  United States
      MD Anderson Cancer Center, Houston,  Texas,  77030,  United States
      UTHSCSA, San Antonio,  Texas,  68284-7881,  United States
      Baylor University Medical Center-Dallas, Dallas,  Texas,  75246,  United States
      Texas Transplant Institute, San Antonio,  Texas,  78229,  United States
Washington
      VA Puget Sound Health Care System, Seattle,  Washington,  98108-1595,  United States
West Virginia
      West Virginia University, Morgantown,  West Virginia,  26506,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
Argentina
      Instituto Alexander Fleming, Buenos Aires,  Argentina
      Fundaleu, Buenos Aires,  Argentina
Australia
      St. Vincent Hospital, Sydney,  Australia
      Royal Melbourne Hospital, Melbourne,  Australia
      Royal Brisbane Hospital, Brisbane,  Australia
      Alfred Hospital, Prahran,  Australia
Austria
      University Clinic for Hematology, Vienna,  Austria
      University Clinic for Internal Medicine Graz, Graz,  Austria
Brazil
      Hospital Das Clinicas Da UFMG, Belo Horizonte,  Brazil
      Hospital Das Clinicas Da Fmusp, Sao Paulo,  Brazil
      Instituto Nacional De Cancer, Rio de Janeiro,  Brazil
      Comite De Etica Em Pesquisa Em Seres, Curitiba,  Brazil
Canada
      Winnipeg Health Sciences Center, Winnipeg,  Canada
      Ottawa Hospital-General Campus, Ottawa,  Canada
      Royal Victoria Hospital, Montreal,  Canada
      Hospital Maisonneuve Rosemont, Montreal,  Canada
      Princess Margaret Hospital, Toronto,  Canada
      McMaster Hospital, Hamilton,  Canada
      Tom Baker Cancer Center, Calgary,  Canada
      Queen Elizabeth II Health Sciences Center, Halifax,  Canada
Czech Republic
      University Hospital Motol, Prague,  Czech Republic
      Institue of Hematology and Blood Transfusion, Prague,  Czech Republic
Denmark
      Hematological Dept. 4042, Copenhagen,  Denmark
Finland
      Helsinki University Central Hospital, Helsinki,  Finland
France
      Institut Paoli-Calmettes, Marseille,  France
      Hopital Henri Mondor, Creteil,  France
      Hopital Hotel Dieu, Nantes,  France
      Institut Gustave Roussy, Villejuif,  France
      Hoptial Edourard Herriot, Lyon,  France
      C.H.R.U. de Lillie, Hospital Claude Huriez, Lille,  France
      Hopital de Hautepierre, Strasbourg,  France
      C.H.U. Hopital De La Miletrie, Poitiers,  France
Germany
      Universitatsklinik Carl Gustart Caros, Dresden,  Germany
      III. Medizinische Klinik und, Mainz,  Germany
      Deutsche Klinik Fuer Diagnostik-DKD, Wiesbaden,  Germany
Greece
      Evangelimos Hospital, Athens,  Greece
Hungary
      National Institute for Hematology and Immunology, Budapest,  Hungary
Italy
      II Divisione di Ematologia, Genova,  Italy
      Divisione di Ematologia, Pavia,  Italy
      Divisone di Ematlogia, Palermo,  Italy
      Ospadali Riuniti Centro, Reggio Calabria,  Italy
      Ospedale La Maddalena, Palermo,  Italy
      Oppedale Civile Centro Trapiati, Pescara,  Italy
Mexico
      Hospital de Especialidades, Mexico City,  Mexico
      Centro Medico National 20 de Mexico City, Mexico City,  Mexico
Netherlands
      University Hospital Utrecht, Utrecht,  Netherlands
      University Hospital Nijmegen, Nijmegen,  Netherlands
Peru
      Hospital Edgardo Rebagliati, Lima,  Peru
Poland
      Department of Hematology and BMT, Katowice,  Poland
Portugal
      Unidade De Transplantacao de Lisboa, Lisboa,  Portugal
      Instituto Portugues de Oncologia do Porto, Porto,  Portugal
Saudi Arabia
      Section of Infectious Diseases, Riyadh,  Saudi Arabia
Singapore
      Singapore General Hospital, Singapore,  Singapore
South Africa
      University of Cape Town, Cape Town,  South Africa
Spain
      Hospital de la Princesa, Madrid,  Spain
      Hospital Marques de Valdecilla, Santander,  Spain
      Hospital Universitario Virgen Del Rocio, Sevilla,  Spain
      Hospital Clinic I Provincial, Barcelona,  Spain
      Hospital Universitario, Valencia,  Spain
      Hospital Reina Sofia, Cordoba,  Spain
      Hospital Universitario de Salamanca, Salamanca,  Spain
      Institut Catala Doncologia, Barcelona,  Spain
Sweden
      Sahlgrenska University Hospital, GOTHENBURG,  Sweden
      Huddinge University Hospital, Stockholm,  Sweden
      Akademiska Hospital, Uppsala,  Sweden
Switzerland
      Kantonsspital Basel, Basel,  Switzerland
United Kingdom
      Hammersmith Hospital, London,  United Kingdom
      Royal London Hospital, London,  United Kingdom
      Hematology University Hosptial of Wales, Wales,  United Kingdom
      John Radcliffe Hospital, Headington,  United Kingdom

Study ID Numbers:  C/I98-316
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  May 1, 2002
ClinicalTrials.gov Identifier:  NCT00034645
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08