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Brief Title: Study of Frontline Dasatinib Plus Chemotherapy in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL)
Official Title: Open Label Phase II Study to Evaluate the Safety of Standard Induction and Consolidation Therapy in Combination With Dasatinib in Newly Diagnosed Adult Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL)
Study ID: NCT01724879
Brief Summary: The current standard treatment approach for young patients with Positive Acute Lymphoblastic Leukemia (Ph+ALL) is the combination of a chemotherapy protocol employing four to five cytotoxic agents typically used for ALL together with imatinib. It is recommended to propose allogeneic Standard Induction and Consolidation Therapy (SCT) to all eligible patients with a suitable donor and to continue imatinib with or without additional therapy in patients not undergoing SCT. This protocol is a study for newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia in patients aged 18 to 55 years. The objective of this strategy is to improve the overall results in the treatment of adult ALL with the addition of specific molecules to the common chemotherapeutic schedule.
Detailed Description: In the present study, the potent ABL tyrosine kinase inhibitor, Dasatinib will be added to standard induction and consolidation chemotherapy for the Philadelphia positive chromosome sub-group of ALL patients aged 18 to 55 years. The Study hypothesis is, that Dasatinib in combination with standard chemotherapy according to GMALL protocol 07/2003 is feasible and induces cytologic and molecular remission rates comparable to chemotherapy in combination with imatinib without increased treatment-related mortality.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Robert Bosch Krankenhaus, Stuttgart, Baden-Württemberg, Germany
Klinikum der Universität Regensburg, Regensburg, Bayern, Germany
University Hospital of Frankfurt, Medical Dept. II, Frankfurt, Hessen, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Universitätsklinikum Essen, Essen, NRW, Germany
Universitätsklinik Münster, Münster, NRW, Germany
Universitätsklinik Dresden, Dresden, Sachsen, Germany
Uniklinik Aachen, Aachen, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
University Hospital Düsseldorf, Düsseldorf, , Germany
Universitätsklinikum Göttingen, Göttingen, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Universitätsklinik Köln, Köln, , Germany
Universität Leipzig, José-Carreras-Haus, Leipzig, , Germany
Universitätskliniken Mainz, Mainz, , Germany
Klinikum Mannheim, Mannheim, , Germany
Universitätsklinikum Großhadern, München, , Germany
Klinikum Nürnberg Nord, Nürnberg, , Germany
Klinikum Oldenburg, Oldenburg, , Germany
Universität Rostock, Rostock, , Germany
Medizinische Universitätsklinik Ulm, Ulm, , Germany
Medizinische Poliklinik der Universität Würzburg, Würzburg, , Germany
Name: Nicola Gökbuget, Dr.med
Affiliation: Johann Wolfgang Goethe University Hospital
Role: PRINCIPAL_INVESTIGATOR