Effectiveness and Safety of InO±DLI for Relapsed B-ALL/LBL After Allo-HSCT

Inclusion criteria

• Aged 14-65 years, male or female;
• Participants with CD22 positive B-ALL/LBL who relapsed after allo-HSCT from a related or unrelated donor (regardless of CD22 expression);
• ECOG physical status score 0~3, Karnofsky score ≥70;
• No active grade III/IV graft-versus-host disease (GvHD) or any active liver GvHD, no history of venous occlusive disease (VOD); No active GvHD and no previous history of VOD;
• Creatinine clearance rate≥50 mL/min (estimate by Cockcroft-Gault Equation);
• Liver function: alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 3×upper limit of normal (ULN), and total bilirubin ≤ 2×ULN;
• Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography;
• Estimated life expectancy >3 months;
• Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.

Exclusion criteria

• Allergic or with a history of serious adverse reactions to drugs or drugs with similar chemical structure in this study;
• Women who are pregnant or breastfeeding, as well as those who are unwilling to take effective contraceptive measures;
• Severe cardiac dysfunction: left ventricular ejection fraction (LVEF) <60%; Or severe arrhythmia: a history of a clinically significant corrected interval (QTc) prolongation (male >450ms; female>470 ms), ventricular tachycardia, atrial fibrillation, second degree atrioventricular block; myocardial infarction and coronary heart disease with clinical symptoms requiring medical treatment within one year before enrollment;
• Severe pulmonary disorders (obstructive or restrictive ventilation disorder);
• Severe liver function impairment: ALT, AST, or TBIL is more than 3 times higher than the upper limit of normal value (ULN);
• Severe renal impairment: serum Cr is more than 2 times higher than the upper limit of normal (ULN); Or 24-hour urinary creatinine clearance <50ml/min;
• Participants with active infection or active bleeding who were deemed intolerance to InO treatment by the investigators;
• A history of new thrombosis, embolism, cerebral hemorrhage or other diseases within one year before enrollment;
• Participants suffer from known or other mental disorders that investigators are unable to obtain informed consent and may interfere with their ability to comply with research requirements;
• A history of major organ surgery within the past six weeks;
• Drug abuse or chronic alcohol abuse that may affect the study results;
• Participants with a history of organ transplantation other than HSCT (except BMT);
• Other situations identified by the investigator as unsuitable to participate in the study.