Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy

Exclusion Criteria

• •1. Mixed lineage leukemia
• •2. Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
• •3. Patients with severe and / or uncontrolled diseases, such as:
• •1. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
• •2. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
• •3. Known to be human immunodeficiency virus positive (HIV+)
• •4. Active and uncontrolled disease/infection as judged by the treating physician
• •5. Active central nervous system (CNS) or extramedullary disease
• •6. Patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study
• •4. Pregnant or nursing women
• •5. Unable or unwilling to sign the consent form
• •6. Monoclonal antibodies therapy within 2 weeks before study entry
• •7. Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry
• •8. Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO
• •9. Patients in other situations who are evaluated by the investigator to be ineligible