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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Dasatinib p.o. + Chemotherapy (Dexamethasone, Cyclophosphamide, Vincristine, Methotroxate, 6-Mercapto-Purine, Cytarabine, Vindesine, VP16 (Etoposide))
Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Klinikum der Universität Regensburg
Regensburg, Bavaria, Germany
University Hospital of Frankfurt, Medical Dept. II
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinik Münster
Münster, North Rhine-Westphalia, Germany
Universitätsklinik Dresden
Dresden, Saxony, Germany
Uniklinik Aachen
Aachen, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinik Köln
Cologne, Germany
...and 12 more locations
Treatment-related discontinuation of study treatment (Proportion of Patients)
Time frame: Day 120
Molecular complete remission rate (CR)
Time frame: Day 120
Hematologic complete remission rate
Time frame: Day 120
Grade III and IV txicity by Common Terminology Criteria for Adverse Events Version 3
Time frame: Day 120
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