36
Participants
Start Date
February 29, 2016
Primary Completion Date
July 31, 2017
Study Completion Date
July 31, 2017
Begelomab
BEGEDINA® (Begelomab) is a murine immunoglobulin G (IgG) 2b monoclonal antibody against CD26 (dipeptidyl peptidase-4; DPP4) and is produced by biotechnological means.
Conventional Second-line Treatment
"There are no approved second-line treatments for aGvHD and due to the life-threatening nature of the disease it was agreed with the FDA and EMA that BEGEDINA® would be compared with best conventional second-line treatments which will be chosen by each center, based on the clinical conditions of the individual subject and according to the standard practice at the study center and which may vary between centers. Treatments are generally biological products and could include anti-thymocyte globulin, monoclonal antibodies, such as anti-CD147, basiliximab, daclizumab and alemtuzumab; mycophenolate mofetil; anti-TNF-alpha; pentostatin; dinileukin diftitox; N-acetyl-cysteine; sirolimus; and visulizumab."
Universitätsspital Basel, Basel
Hospital Saint-Louis APHP (Hôpitaux Universitaires Sant-Louis), Paris
Memorial Sloan Kettering Cancer Center, New York
Ospedale Molinette, Torino
L'IRCCS A.O.U. San Martino - IST, Genova
Ospedale San Raffaele, Milan
Universitätsklinikum Hamburg-Eppendorf, Hamburg
Duke Cancer Center, Durham
Hospital Univeristario de Salamanca, Salamanca
Centre Hospitalier Universitaire de Grenoble, La Tronche
Policlinico S.Orsola Malpighi, AOU di Bologna, Bologna
The Ohio State University, Columbus
Hospital Universitari Politecnic La Fe, Valencia
Washington University School of Medicine, St Louis
University of Kansas Cancer Center and Medical Pavilion, Westwood
Centre Hospitalier Lyon-Sud, Pierre-Bénite
Ospedale Casa Sollievo della Sofferenza, IRCCS, San Giovanni Rotondo
Huntsman Cancer Center, University of Utah, Salt Lake City
City of Hope Comprehensive Cancer Center, Duarte
Oregon Health & Science University, Portland
Dana-Farber Cancer Institute, Boston
Hackensack University Medical Center - John Theurer Cancer Center, Hackensack
A.O. Universitaria Policlinico Tor Vergata, Roma
Policlinico Universitario Agostino Gemelli, Roma
Hospital Universitari Vall d'Hebron, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
University Hospital Southampton NHS Foundation Trust, Southampton
Lead Sponsor
ADIENNE S.r.l. S.U.
UNKNOWN
Adienne SA
INDUSTRY