Study of Inotuzumab Ozogamicin with Chemotherapy for Adults with Acute Lymphoblastic Leukemia Evaluating Dose and Safety

What this Trial Is About

Researchers are evaluating the side effects, best dose, and effectiveness of inotuzumab ozogamicin combined with low-intensity chemotherapy in treating adults with acute lymphoblastic leukemia ALL. This phase III trial focuses on elderly patients and those unfit for intensive therapy, aiming to find the maximum tolerated dose and response in different patient groups. The study also explores genetic factors and advanced disease detection methods to better understand treatment outcomes. Participants are assigned to one of three treatment groups. Treatments involve cycles of various drugs including inotuzumab ozogamicin, chemotherapy agents like cyclophosphamide, vincristine, dexamethasone, methotrexate, cytarabine, and biological agents such as blinatumomab and rituximab. Treatments are given intravenously, orally, intrathecally, or as continuous infusions over several weeks, with maintenance therapy lasting up to three years. Cycles repeat every 3 to 6 weeks depending on the arm, and treatment continues unless disease progression or unacceptable side effects occur. Participants undergo regular monitoring including clinical exams and laboratory tests throughout the treatment and maintenance phases. After completing study treatment, patients have follow-up visits at 30 days and every 4 months to assess safety and effectiveness. Researchers measure outcomes such as maximum tolerated dose, progression-free survival, response rate, and survival over periods ranging from 28 days to several years. The total participation duration varies by treatment arm and patient condition.

Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia