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

Data management at EORTC

Yes

Design

Phase 2
Not randomized / N.A.

Targeted Sample size

EORTC Groups: 150 - All Groups: 150

Treatment

Radiotherapy, Drug
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

EudraCT