Study
EORTC-1537-LYMG-COBRA
Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study
Trial Status
Closed to Patient Entry
Dates
Date of activation: 30-Jul-2019
Date Step1 close: 31-Aug-2021
Date Step1 close: 31-Aug-2021
Data management at EORTC
Yes
Design
Phase 2
Not randomized / N.A.
Not randomized / N.A.
Targeted Sample size
EORTC Groups: 150 - All Groups: 150
Treatment
Radiotherapy, Drug
Cyclophosphamide, Dacarbazine, Doxorubicin, Etoposide, Vinblastine, Dexamethasone, Brentuximab vedotin
Cyclophosphamide, Dacarbazine, Doxorubicin, Etoposide, Vinblastine, Dexamethasone, Brentuximab vedotin
Study Staff
- Martin Hutchings (Study Coordinator), Rigshospitalet, Copenhagen
- Sarah Nuyens (Project Manager), EORTC Headquarters, Brussels
- Ward Sents (Clinical Scientist), EORTC Headquarters, Brussels
- Lydia Champezou (Statistician), EORTC Headquarters, Brussels
- Cedric Mallien (TR Scientist), EORTC Headquarters, Brussels
- Laila Ben Salama (Clinical Operations Manager), EORTC Headquarters, Brussels
- Shani De Coster (Data Manager), EORTC Headquarters, Brussels
- Axelle Nzokirantevye (Imaging DM), EORTC Headquarters, Brussels
- Leen Wijnen (Imaging DM), EORTC Headquarters, Brussels
- Bart Meulemans (Clinical Data Expert), EORTC Headquarters, Brussels
- Zara Nasir (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Jelle Stans (Regulatory Affairs Manager), EORTC Headquarters, Brussels
- Miguel Remis (Lead CRA), EORTC Headquarters, Brussels
- Stefanos Soraruff (Clinical Operations Assistant), EORTC Headquarters, Brussels
- Hafida Lmalem (Imaging Officer), EORTC Headquarters, Brussels
- Lucy Sepulveda (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
- Laure Musekera (Statistical Fellow), EORTC Headquarters, Brussels
- Enrico Clementel (RTQA Manager), EORTC Headquarters, Brussels
- Catherine Fortpied (Lead Statistician), EORTC Headquarters, Brussels
Type of cancer
- Hodgkins Disease
Participating groups
- EORTC Lymphoma Group
Recruiting centers
- Amsterdam UMC stichting - Locatie AMC (Amsterdam, Netherlands)
- Deventer Ziekenhuis (Deventer, Netherlands)
- Erasmus MC (Rotterdam, Netherlands)
- Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
- Hospital Universitario de Navarra (Pamplona, Spain)
- ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal)
- Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland)
- Maxima Medisch Centrum - Locatie Veldhoven (Veldhoven, Netherlands)
- Medisch Centrum Leeuwarden-Zuid (Leeuwarden, Netherlands)
- Narodny Onkologicky Ustav - Bratislava (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)
- ZAS CADIX (Antwerpen, Belgium)
Protocol summary
NCT number
NCT03517137