Clinical Trial Details
EORTC-65091-06093-IDG-LG
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Empirical versus pre-emptive (diagnostic-driven) antifungal therapy of patients treated for haematological malignancies or receiving an allogeneic stem cell transplant. A therapeutic open label phase III strategy study of the EORTC Infectious Diseases and Leukemia Groups
Trial Status | Closed to Patient Entry |
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Dates |
Date of activation: 08-Mar-2012 Date Step1 close: 30-Sep-2015 |
Data management at EORTC | Yes |
Design |
Phase 3 Randomized open label |
Targeted Sample size | EORTC Groups: 556 - All Groups: 556 |
Treatment |
Drug Caspofungin |
Study Staff |
Peter Donnelly (Study Coordinator) , , Peter De Burghgraeve (Data Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Marianne Paesmans (Statistician) , Institut Jules Bordet, Anderlecht Ellen Peeters (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels Tim Verbiest (Data Manager) , EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels |
Type of cancer |
Acute Myelogenous Leukemia Myelodysplastic Syndroms Infectious Disease : Fungal |
Participating groups |
EORTC Leukemia Group EORTC Infectious Diseases Group |
Recruiting centers |
A.Z. St. Jan (Brugge, Belgium) APHP - Hop. Univ. Henri Mondor (Creteil, France) C.H.U. Sart-Tilman (Liege, Belgium) CHRU de Lille - Hopital Huriez (Lille, France) CHU de Caen - Hopital Cote de Nacre (CAEN CEDEX 9, France) CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Fakultni nemocnine Brno - Univ. Hospital Brno (Brno, Czech Republic) Gustave Roussy (VILLEJUIF CEDEX, France) Gustave Roussy (VILLEJUIF CEDEX, France) Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg Cedex 1, France) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universitaetsklinikum Freiburg (Freiburg, Germany) Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik I, II (Wuerzburg, Germany) |
Protocol summary | http://clinicaltrials.gov/study/NCT01288378 |
NCT number | NCT01288378 |
EudraCT | 2010-020814-27 |
Financial Support | Educational Grant |