Clinical trial NCT02744768 (phase 2, status: recruiting)
Conditions: acute lymphoblastic leukemia
ICD codes: C91.01, C91.02, C91.00
Drugs: dasatinib, blinatumomab
SMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed adult B-precursor Ph+ ALL patients.

          -  Age greater or equal to18 years,

          -  Signed written informed consent according to ICH/EU/GCP and national local laws.

          -  ECOG Performance Status 0 or 1 and/or WHO performance status less or equal to 2.

          -  Renal and hepatic function as defined below:

               -  AST (GOT), ALT (GPT), and AP <2 x upper limit of normal (ULN).

               -  Total bilirubin <1.5 x ULN.

               -  Creatinine clearance equal or greater than 50 mL/min.

          -  Pancreatic function as defined below:

               -  Serum amylase less or equal to 1.5 x ULN

               -  Serum lipase less or equal to1.5 x ULN.

          -  Normal cardiac function.

          -  Negative HIV test, negative HBV DNA and HCV RNA.

          -  Negative pregnancy test in women of childbearing potential.

          -  Bone marrow specimen from primary diagnosis available.

        Exclusion Criteria:

          -  History of or current relevant CNS pathology (current ≥grade 2 epilepsy, seizure,
             paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia,
             Parkinson's disease, organic brain syndrome, psychosis).

          -  Impaired cardiac function, including any one of the following:

               -  LVEF <45% as determined by MUGA scan or echocardiogram.

               -  Complete left bundle branch block.

               -  Use of a cardiac pacemaker.

               -  ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more
                  contiguous leads.

               -  Congenital long QT syndrome.

               -  History of or presence of significant ventricular or atrial arrhythmia.

               -  Clinically significant resting bradycardia (<50 beats per minute).

               -  QTc >450 msec on screening ECG (using the QTcF formula).

               -  Right bundle branch block plus left anterior hemiblock, bifascicular block.

               -  Myocardial infarction within 3 months prior to starting Dasatinib.

               -  Angina pectoris.

          -  Other clinically significant heart disease (e.g., congestive heart failure,
             uncontrolled hypertension, history of labile hypertension, or history of poor
             compliance with an antihypertensive regimen).

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of Dasatinib (e.g., ulcerative diseases, uncontrolled nausea,
             vomiting, diarrhea, malabsorption syndrome, or small bowel resection).

          -  History of or current autoimmune disease.

          -  Systemic cancer chemotherapy within 2 weeks prior to study.

          -  Known hypersensitivity to immunoglobulins or to any other component of the study drug
             formulation.

          -  Active malignancy other than ALL with the exception of basal cell or squamous cell
             carcinoma of the skin, or carcinoma "in situ" of the cervix.

          -  Active infection, any other concurrent disease or medical conditions that are deemed
             to interfere with the conduct of the study as judged by the investigator.

          -  Nursing women or women of childbearing potential not willing to use an effective form
             of contraception during participation in the study and at least 3 months thereafter or
             male patients not willing to ensure effective contraception during participation in
             the study and at least three months thereafter.