A multicentre, randomized trial in adults with de novo Philadelphia-Chromosome positive acute lymphoblastic leukemia to assess the efficacy of ponatinib versus imatinib in combination with low-intensity chemotherapy, to compare end of therapy with indication for SCT versus TKI, blinatumomab and chemotherapy in optimal responders and to evaluate blinatumomab in suboptimal responders (GMALL-EVOLVE)

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• History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions: o Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease o Adequately treated cervical carcinoma in situ without evidence of disease o Adequately treated breast ductal carcinoma in situ without evidence of disease o Prostatic intraepithelial neoplasia without evidence of prostate cancer, Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab, Patient previously treated with tyrosine kinase inhibitors, Nursing women, Known impaired cardiac function, including any of the following: o LVEF < 40% o Complete left bundle branch block o Right bundle branch block plus left anterior hemiblock, bifascicular block o History of or presence of clinically significant ventricular or atrial tachyarrhythmias o Clinically significant resting bradycardia (< 50 beats per minute) o Congenital long QT syndrome or QTcF >470 msec for females and >450 msec for males on screening ECG. If QTc > 470 msec for females and > 450 msec for males and electrolytes are not within normal ranges before ponatinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF crite- rion. o Myocardial infarction within 12 months prior to starting study treatment o Other clinically significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension), Symptomatic peripheral vascular disease, Any history of ischemic stroke or transient ischemic attacks (TIAs), Uncontrolled hypertriglyceridaemia, History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, cerebrovascular ischemia/haemorrhage, severe brain injuries, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis (with exception of CNS leukemia that is well controlled with intrathecal therapy), History or active relevant autoimmune disease, Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation, Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not man- datory) or active infection with Hepatitis B or C, History of pancreatitis within 6 months previous to start of treatment within the trial, Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study, Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of noral or > 5 times ULN if considered due to leukemia, Total bilirubin > 1.5-fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert / M. Meulengracht, Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections, Inability to understand and/or unwillingness to sign a written informed consent