AALL 1732: 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.

Are you Eligible? (Inclusion Criteria)

• >Patient must be >365 days and < 25 years of age >Patient has newly diagnosed high risk B-lymphoblastic leukemia (HR B-ALL), mixed phenoype acute leukemia (MPAL), or disseminated (Murphy stage III or IV) B- lymphoblastic lymphoma (B-LLy) >Patient must must meet all eligibility criteria as outlined in the study protocol