Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia
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
• Patients who have/are either:
‣ 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
⁃ Leukemia
⁃ Relapsed or refractory to at least 1 line of treatment
⁃ Minimal residual disease(MRD) positive before HSCT, including flow cytometry and cytogenetic test
• Patients who have \> 99% donor chimerism after allogeneic transplantation.
• Eastern Cooperative Oncology Group(ECOG) Performance status ≤ 2
• Participants must have ANC \> 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count \> 50,000/µL for 7 days.
• ≥ 18 years old, including male and female
• Participants must have the ability to understand and the willingness to sign a written informed consent document.