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

AALL1732 is a Children's Oncology Group (COG) group-wide Phase 3 study for patients between the ages of 1-25 years with newly diagnosed high risk B-lymphoblastic leukemia (HR B-ALL), mixed phenotype acute leukemia (MPAL), or disseminated (Murphy stage III or IV) B-lymphoblastic lymphoma (B-LLy). Patients with HR B-ALL will be stratified into HR favorable B-ALL (HR-Fav) or HR B-ALL, and this study will assess whether the incorporation of two blocks of inotuzumab ozogamicin (InO) into a modified Berlin-Frankfurt-Münster (mBFM) chemotherapy backbone will improve the disease-free survival (DFS) for patients with HR B-ALL. There will be no randomization for other patient groups (HR-Fav, MPAL, and B-LLy), who will receive mBFM chemotherapy with one (HR-Fav) or two (MPAL and B-LLy) Interim Maintenance (IM) phases and will have DFS or event-free survival (EFS) described. Of note, the duration of Maintenance therapy will be two years from the start of the phase following Consolidation (either the first IM phase or the first InO course), regardless of sex.