28
Participants
Start Date
March 31, 2012
Primary Completion Date
November 30, 2014
Study Completion Date
April 30, 2017
NOX-A12
"Pilot Group (NOX-A12 single agent, and combined with BR):~* 3 cohorts of 3 patients will receive treatment with NOX-A12 alone at a single dose of 1, 2 or 4 mg/kg i.v. 2 weeks before the combination treatment of NOX-A12 and BR begins.The combination of NOX-A12 and BR will follow a dose titration design beginning at 1 mg/kg NOX-A12 (cycle 1), proceeding to dose levels of 2 mg/kg (cycle 2) and 4 mg/kg (cycle 3) NOX-A12 in combination with BR. This is followed by consolidation in cycles 4-6 when NOX-A12 will be kept at the highest individually titrated dose.~Expansion Group (NOX-A12 in combination with BR):~* Expansion patients will not receive single agent NOX-A12, but will receive combination treatment as for the pilot group."
Medical University Innsbruck, Division of Hematology and Oncology, Innsbruck
University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology, Salzburg
Landeskrankenhaus Steyr, Department of Internal Medicine II (Hematology and Oncology), Steyr
Hospital Wels-Grieskrichen, Department of Internal Medicine IV (Hematology and Oncology), Wels
Cliniques universitaires Saint-Luc, Brussels
Institute Jules Bordet, Department of Hematology, Brussels
University Hospital Gasthuisberg, Department of Hematology, Leuven
Centre Hospitalier Universitaire Clémenceau, Department of Hematology, Caen
Hospices Civils, Department of Hematology, Lyon
Centre Hospitalier Universitaire de la Milétrie, Department of Hematology, Poitiers
University Hospital, Institute of Hematology and Oncology, Bologna
Azienda Sanitaria Locale 8, Department of Oncology, Cagliari
University Hospital San Martino, Department of Hematology and Oncology, Genova
Niguarda Ca'Granda Hospital, Milan
University Scientific Research Institute San Raffaele, Milan
University School of Medicine, Department of Hematology, Padua
University La Sapienza, Department of Cellular Biotechnologies and Hematology, Rome
TME Pharma AG
INDUSTRY