Study
EORTC-1652-CLTG
Phase II trial of atezolizumab (anti-PD-L1) in the treatment of stage IIb-IV mycosis fungoides/sezary syndrome patients relapsed/refractory after a previous systemic treatment
Trial Status
Closed to Patient Entry
Dates
Date of activation: 12-Sep-2018
Date Step1 close: 21-Nov-2019
Date Step1 close: 21-Nov-2019
Data management at EORTC
Yes
Design
Phase 2
Not randomized / N.A.
Not randomized / N.A.
Targeted Sample size
EORTC Groups: 29 - All Groups: 29
Treatment
Drug
Atezolizumab
Atezolizumab
Study Staff
- Robert Knobler (Study Coordinator), Universitaetsklinikum Wien - AKH unikliniken, Vienna
- Rudolf Stadler (Study Coordinator), Muehlenkreiskliniken Johannes Wesling Klinikum Minden, Minden
- Jose Casas (TR Scientist), EORTC Headquarters, Brussels
- Leslie Herman (Regulatory Affairs Manager), EORTC Headquarters, Brussels
- Sandrine Marreaud (Clinical Research Physician), EORTC Headquarters, Brussels
- Jammbe Musoro (Statistician), EORTC Headquarters, Brussels
- Valentina Pomella (Clinical Operations Manager), EORTC Headquarters, Brussels
- Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Denisse Tubay (Pharmacovigilance Manager), EORTC Headquarters, Brussels
- Katheline Vander Heggen (Regulatory Affairs Administrator), EORTC Headquarters, Brussels
Type of cancer
- Primary Cutaneous Lymphomas
Participating groups
- EORTC Cutaneous Lymphoma Tumor Group
Recruiting centers
- APHP Nord - Univ De Paris Cite - Hop. Saint Louis (Paris, France)
- Athens University - Attikon University General Hospital (Athens, Greece)
- Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Lazzaro (Torino, Italy)
- Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
- Hospital Del Mar (Barcelona, Spain)
- Hospital Universitario 12 De Octubre (Madrid, Spain)
- Muehlenkreiskliniken Johannes Wesling Klinikum Minden (Minden, Germany)
- UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom)
- UniversitaetsSpital Zurich - Division of Dermatology (Zurich, Switzerland)
Protocol summary
NCT number
NCT03357224