Phase II Study of Sequential Hyper-CVAD, Blinatumomab, and Inotuzumab Ozogamicin as First Treatment for Adults With B-Cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating how well a combination of blinatumomab, inotuzumab ozogamicin, and chemotherapy works as an initial treatment for patients with B-cell acute lymphoblastic leukemia ALL. This phase II trial aims to assess relapse-free survival and other outcomes like overall survival, response rate, and safety using this combined approach. The study also explores genetic factors that may predict treatment response and compares different methods for detecting minimal residual disease. During the intensive phase, patients receive a detailed chemotherapy regimen including drugs like cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, with some receiving additional antibodies like ofatumumab or rituximab. This phase lasts up to four cycles with treatments given on specific days. The next phase includes blinatumomab given continuously for four weeks and inotuzumab ozogamicin administered intravenously on certain days, repeated every six weeks for up to four cycles. A maintenance phase may follow, where patients receive oral and intravenous medications such as mercaptopurine, methotrexate, vincristine, prednisone, and blinatumomab over about 12 months. Participants will have monthly follow-up visits for up to 24 months after completing treatment. Assessments include monitoring for disease relapse, survival, response rates, and side effects. The study also involves laboratory biomarker analysis and genetic testing to understand treatment effects better. Safety and efficacy outcomes will be tracked throughout the study period to evaluate the combination therapys impact on B-cell ALL.

Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia