To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.
Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia
Patients who are after T+60 after transplantation
High risk B-ALL: (1) high white blood cell(WBC) count when newly diagnosed, (2) Poor risk group according to NCCN guideline 2021 of Acute Lymphoblastic
Patients with evidence of disease progression prior to enrollment
Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
Severe renal deficiency, with creatinine clearance < 50ml/min
Severe hepatic deficiency
Single group
Inotuzumab ozogamicin
Drug1. st dose is given after D+60：inotuzumab 0.3mg/m2 2. nd dose is given after 1 month：inotuzumab 0.6mg/m2
DFS
Efficacy as measured by DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of HSCT to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)".
Overall survival
Defined from time from HSCT to death due to any cause Defined from time from date of HSCT to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI Difference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10
Relapse
Defined as time from date of HSCT to the date of first relapse. Reported as Cumulative Incidence
NRM
Defined as time from date of first dose to death due to any cause without prior relapse.
Incidence of hematological toxicity
Number of patients who develop hematological toxicity while on study, defined as grade of anemia, neutropenia and thrombocytopenia, etc.
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