Spots Global Cancer Trial Database for NOX-A12 in Combination With Bendamustine and Rituximab in Relapsed Chronic Lymphocytic Leukemia (CLL)
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Trial Identification
Brief Title: NOX-A12 in Combination With Bendamustine and Rituximab in Relapsed Chronic Lymphocytic Leukemia (CLL)
Official Title: A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bendamustine and Rituximab (BR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)
Study ID: NCT01486797
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of NOX A12 in combination with a background therapy of bendamustine and rituximab (BR) chemotherapy in previously treated patients with chronic lymphocytic leukemia (CLL).
Detailed Description: CLL cells express high levels of CXCR4 chemokine receptors, which cause leukemia cell migration and adhesion to stromal cells secreting the CXCR4 ligand, CXCL12 (or stromal-derived-factor 1, SDF-1). NOX A12 is a specific CXCL12 antagonist and may improve BR therapy by disrupting CXCR4-CXCL12 interactions, thereby mobilizing CLL cells from protective tissue microenvironments to the blood. Furthermore, SDF-1 inhibition may alter the activation status of CLL cells, thereby triggering apoptosis or sensitization of CLL cells towards chemotherapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical University Innsbruck, Division of Hematology and Oncology, Innsbruck, , Austria
University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology, Salzburg, , Austria
Landeskrankenhaus Steyr, Department of Internal Medicine II (Hematology and Oncology), Steyr, , Austria
Hospital Wels-Grieskrichen, Department of Internal Medicine IV (Hematology and Oncology), Wels, , Austria
Cliniques universitaires Saint-Luc, Brussels, , Belgium
Institute Jules Bordet, Department of Hematology, Brussels, , Belgium
University Hospital Gasthuisberg, Department of Hematology, Leuven, , Belgium
Centre Hospitalier Universitaire Clémenceau, Department of Hematology, Caen, , France
Hospices Civils, Department of Hematology, Lyon, , France
Centre Hospitalier Universitaire de la Milétrie, Department of Hematology, Poitiers, , France
University Hospital, Institute of Hematology and Oncology, Bologna, , Italy
Azienda Sanitaria Locale 8, Department of Oncology, Cagliari, , Italy
University Hospital San Martino, Department of Hematology and Oncology, Genova, , Italy
Niguarda Ca'Granda Hospital, Milano, , Italy
University Scientific Research Institute San Raffaele, Milano, , Italy
University School of Medicine, Department of Hematology, Padova, , Italy
University La Sapienza, Department of Cellular Biotechnologies and Hematology, Rome, , Italy
Contact Details
Name: Kai Riecke, MD
Affiliation: TME Pharma AG
Role: STUDY_DIRECTOR
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