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Spots Global Cancer Trial Database for Study of Frontline Dasatinib Plus Chemotherapy in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL)

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Trial Identification

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

Interventions

Dasatinib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Nicola Gökbuget, Dr.med

Affiliation: Johann Wolfgang Goethe University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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