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

Korábbi kezelés

• Patients with severe and / or uncontrolled diseases, such as:
  • 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)
  • Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
  • Known to be human immunodeficiency virus positive (HIV+)
  • Active and uncontrolled disease/infection as judged by the treating physician
  • Active central nervous system (CNS) or extramedullary disease
  • 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
• Monoclonal antibodies therapy within 2 weeks before study entry
• Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry

Más betegség

• Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
• Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO

Egyéb

• Mixed lineage leukemia
• Pregnant or nursing women
• Unable or unwilling to sign the consent form
• Patients in other situations who are evaluated by the investigator to be ineligible

• New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
• Age ≥18 years
• ECOG PS score: 0 to 2
• Functions of the main organs are normal, if the following criteria are met:
  • Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN
  • Serum creatinine ≤ 1.5 × ULN
  • Creatinine clearance ≥ 30 ml/min
• No active or co-existing malignancy with a life expectancy of less than 12 months
• Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed.