A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
Primary Aim To determine in a randomized manner if the addition of 2 blocks of inotuzumab ozogamicin to modified Berlin-Frankfurt-Munster (mBFM) chemotherapy will improve 5-year disease-free survival (DFS) in children and young adults with High-Risk (HR) B-cell acute lymphoblastic leukemia (B-ALL).
Secondary Aims To describe the 5-year DFS for a favorable risk subset of NCI HR B-ALL (HR-Fav) when treated with mBFM chemotherapy with a single high-dose methotrexate (HD-MTX) Interim Maintenance (IM) phase and treatment duration of 2 years from the start of IM regardless of sex. To determine the toxicity and tolerability of inotuzumab ozogamicin integrated into the mBFM chemotherapy backbone in HR B-ALL. To describe the 5-year event-free survival (EFS) for patients with Mixed Phenotype Acute Leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi escalating intravenous (IV) methotrexate (MTX) without leucovorin rescue plus pegaspargase (C-MTX). To describe the 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM phase with C-MTX.