About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Inotuzumab ozogamicin