Study of Inotuzumab Ozogamicin After Stem Cell Transplant for Acute Lymphocytic Leukemia Phase I Dose-Finding and Phase II Safety and Effectiveness Evaluation

What this Trial Is About

Researchers are evaluating inotuzumab ozogamicin, an experimental combination of an antibody and chemotherapy, for patients with CD22-positive acute lymphocytic leukemia ALL who have undergone allogeneic stem cell transplantation and are at high risk of relapse. This study includes two phases Phase I focuses on determining safe dosing levels after transplant, while Phase II aims to monitor side effects and assess the treatments efficacy in preventing disease relapse. In Phase I, participants receive escalating doses of inotuzumab ozogamicin intravenously, with dose adjustments ranging from 0.1 to 0.6 mgm2 based on tolerability, for up to 4 cycles. Phase II follows with treatment at the recommended Phase II dose of 0.3 mgm2 every 28 days for up to 4 cycles. Treatment continues until disease relapse, unacceptable side effects, or death. The study monitors safety, tolerability, and pharmacokinetics throughout. Participants will undergo regular clinical and laboratory assessments to track side effects, disease status, and survival outcomes up to one year after treatment initiation. Key measurements include disease-free survival, relapse rates, non-relapse mortality, and overall survival. Safety evaluations focus on myeloid toxicity, graft failure, and liver complications. Participants must adhere to visit schedules and provide informed consent. The entire study spans several months with close monitoring during and after treatment cycles.

Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia