Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia

Exclusion Criteria

• •More than 5% of BM blasts.
• •WHO performance status ≤ 50% (Karnofsky) or ≥ 3 (ECOG).
• •Active HBV or HCV hepatitis, or AST/ALT ≥ 2.5 x ULN and bilirubine ≥ 1.5 x ULN.
• •Evidence of liver fibrosis, portal hypertension or other clinically relevant liver abnormalities at screening liver ultrasonography.
• •History of alcohol abuse.
• •Burkitt lymphoma and active CNS leukemia. Patients with previuos neurological toxicitiy as well co-morbidity will be carefully evaluated for enrolment.
• •Ongoing or active infections.
• •Uncontrolled hypertriglyceridemia (triglycerides \>450 mg/dL). Clinically significant, uncontrolled, or active cardiovascular disease.
• •Uncontrolled hypertension (diastolic blood pressure \>90 mm Hg; systolic \>140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
• •Creatinine level \> 2.5mg/dl or Glomerular Filtration Rate (GFR) \< 20 ml/min or proteinuria \> 3.5 g/day.
• •Documented inherited protrombotic disorders
• •Patients who have received any investigational drug ≤ 4 weeks.
• •Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
• •Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention or with a life expectancy due to other malignancy \<6 months.
• •Patients that have received Inotuzumab or Anti CD22 directed therapies before
• •Patients with known hereditary coagulopathy
• •Patient that received during their life diagnosis of VOD or had ongoing VOD
• •Patients who are pregnant or breastfeeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 4 months following discontinuation of study drugs.
• •Patients unwilling or unable to comply with the protocol.