Clinical Trial Details

EORTC-1537-LYMG

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Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study

Study documentation

Trial Status Recruiting
Dates Date of activation: 30-Jul-2019
Data management at EORTC Yes
Design Phase 2
Not randomized / N.A.
Targeted Sample size EORTC Groups: 150 - All Groups: 150
Treatment Drug
Cyclophosphamide, Dacarbazine, Doxorubicin, Etoposide, Vinblastine, Dexamethasone, Brentuximab vedotin
Study Staff Anne-Sophie Govaerts (Study Coordinator) , EORTC Headquarters, Brussels
Martin Hutchings (Study Coordinator) , Rigshospitalet, Copenhagen
Cherelle Clarke (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Enrico Clementel (QART Manager) , EORTC Headquarters, Brussels
Bianca Colleoni (Clinical Operations Manager) , EORTC Headquarters, Brussels
Ruxandra Dionisie (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels
Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Selin Gundogan (Clinical Operations Manager) , EORTC Headquarters, Brussels
Hafida Lmalem (Imaging Officer) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Sarah Nuyens (Project Manager) , EORTC Headquarters, Brussels
Axelle Nzokirantevye (Imaging DM) , EORTC Headquarters, Brussels
Bassem Osmani (Data Manager) , EORTC Headquarters, Brussels
Aleksandra Peric (Clinical Operations Manager) , EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Ward Sents (Clinical Scientist) , EORTC Headquarters, Brussels
Carmen Sobrino (Lead CRA) , EORTC Headquarters, Brussels
Jelle Stans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Leen Wijnen (Imaging DM) , EORTC Headquarters, Brussels
Gaetan de Schaetzen (Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer Hodgkins Disease
Participating groups EORTC Lymphoma Group
Recruiting centers Complejo Hospitalario de Navarra (Pamplona, Spain)
Deventer Ziekenhuis (Deventer, Netherlands)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
Instituto Portugues De Oncologia - Francisco Gentil - Centro De Lisboa (Lisboa, Portugal)
Maria Sklodowska Curie - Curie’s National Institute of Oncology – National Research Institute (Warsaw, Poland)
Medisch Centrum Leeuwarden-Zuid (Leeuwarden, Netherlands)
National Cancer Institute (Bratislava, Slovakia)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Rigshospitalet (Copenhagen, Denmark)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University Medical Center Groningen (Groningen, Netherlands)
ZNA Stuivenberg (Antwerpen, Belgium)
Centers to be activated Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Cork University Hospital (Cork, Ireland)
Erasmus MC (Rotterdam, Netherlands)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
Herlev Hospital - University Copenhagen (Herlev, Denmark)
Hospital Del Mar (Barcelona, Spain)
Mater Misericordia Hospital (Dublin, Ireland)
Maxima Medisch Centrum - Locatie Eindhoven (Eindhoven, Netherlands)
Medisch Spectrum Twente (Enschede, Netherlands)
National Cancer Institute (Cairo, Egypt)
St. James'S Hospital (Dublin, Ireland)
University Hospital Centre Zagreb (Zagreb, Croatia)
University Hospital Galway (Galway, Ireland)
Protocol summary http://clinicaltrials.gov/ct/show/NCT03517137
NCT number NCT03517137
EudraCT 2017-000498-35
Financial Support Educational Grant