28
Participants
Start Date
March 31, 2012
Primary Completion Date
September 30, 2014
Study Completion Date
September 30, 2015
NOX-A12
"Pilot Group (NOX A12 single agent, and combined with VD):~* 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 VD will start. The combination of NOX A12 and VD 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 VD. This is followed by consolidation in cycles 4-8 when NOX-A12 will be kept at the highest individually titrated dose.~Expansion Group (NOX A12 in combination with VD):~* Expansion patients will not receive single agent NOX-A12, but will receive combination treatment as for the pilot group."
University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology, Salzburg
Wilhelminenspital, Department of Medicine I, Center of Oncology and Hematology, Vienna
Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille, Lille
Hôpital Saint Antoine - Service des maladies du sang et de thérapie cellulaire, Paris
University Hospital Freiburg, Medizinische Universitätsklinik, Innere Medizin I, Haematologie und Onkologie, Freiburg im Breisgau
University Hospital Münster, Medizinische Klinik und Poliklinik A, Münster
University Hospital Ulm, Zentrum für Innere Medizin,, Ulm
University Hospital San Martino, Department of Hematology and Oncology, Genova
Niguarda Ca'Granda Hospital, Department of Hematology, Milan
Sapienza University of Rome, Department of Hematology, Rome
TME Pharma AG
INDUSTRY