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)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related discontinuation of study treatment (Proportion of Patients)
Day 120
Yes
Oliver G. Ottmann, Prof.Dr.med
Principal Investigator
Johann Wolfgang Goethe University Hospitals
Germany: Federal Institute for Drugs and Medical Devices
GMALL-PH-01
NCT01724879
November 2011
May 2014
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