Study of Inotuzumab Ozogamicin for Treating Minimal Residual Disease Recurrence After Stem Cell Transplant in Adults with Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are studying the use of Inotuzumab Ozogamicin to treat patients with acute lymphoblastic leukemia ALL who have minimal residual disease MRD recurrence after undergoing hematopoietic stem cell transplantation HSCT. MRD positivity after HSCT is linked to a high recurrence rate and poorer outcomes. This study aims to explore the safety and effectiveness of Inotuzumab Ozogamicin in maintaining MRD-negative status and improving long-term survival for these patients. Participants will receive Inotuzumab Ozogamicin through intravenous infusion in cycles lasting 21 days each. In the first cycle, doses are given on days 1, 8, and 15 with specific amounts. If MRD becomes negative, the second cycle uses a lower dosing schedule if not, the cycle 2 dosing remains the same as cycle 1. This approach evaluates how the drug impacts MRD status after transplantation. During the study, participants will be monitored for MRD status at the end of each cycle, with the primary outcome being the rate of MRD negativity. Long-term outcomes such as progression-free survival, overall survival, and adverse events affecting blood and other organs will be tracked over one year. Safety and treatment effects will be carefully assessed through clinical evaluations and laboratory tests throughout the study period.

Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL