d-alba frontline sequential dasatinib and blinatumomab in adult philadelphia positive acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of blinatumomab, in adult ph+ all.


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.

Keywords: acute lymphoblastic leukemia, adult, dasatinib, blinatumomab