AALL1732: 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

Brief description of study

This is a Children's Oncology Group (COG) phase 3 trial for children (ages 1-25 years) newly diagnosed with 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. The primary aim of this study is to assess in a randomized fashion whether or not the incorporation of two cycles of inotuzumab ozogamicin (InO) into a modified Berlin-Frankfurt-Munster (mBFM) chemotherapy backbone will improve disease-free survival. InO is an antibody drug conjugate composed of a humanized IgG monoclonal CD22-targeted antibody linked to calicheamicin, a potent antitumor antibiotic. Patients in the other groups will not receive InO but instead will receive mBFM with one interim maintenance (HR-Fav) or two interim maintenance (MPAL and B-LLy) phases. Maintenance duration will be two years following consolidation for all patients regardless of sex.


Clinical Study Identifier: s19-01819
ClinicalTrials.gov Identifier: NCT03959085
Principal Investigator: Elizabeth A Raetz.
Other Investigators: Nicole Mallory, Ashley Pinchinat, Sharon L Gardner, William L Carroll, Jessica Clymer, Kirsty Hillier, Gloria Paz Contreras Yametti, Gabriel Andrew Robbins, Elizabeth Ann Roman.


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