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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

NCT03959085

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

Associated Conditions

Leukemia

Principal Investigator

Sponsor

Children's Oncology Group

Disseminated B-Cell Lymphoblastic Lymphoma (B-LLy): The overall goal of this study is to determine the outcomes of subjects with disseminated B-LLy receiving High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL) therapy. Mixed Phenotype Acute Leukemia (MPAL): The overall goal of this study is to determine the outcomes of subjects with MPAL with a favorable early response to treatment receiving High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL) therapy. Part 1: Induction and Consolidation Therapy for Subjects with B-cell Acute Lymphoblastic Leukemia (B-ALL): The overall goal of Part 1 of the study is to collect information about your leukemia and the effects of the first two phases of treatment, called Induction and COnsolidation. Part 2: Post-Consolidation Therapy for Subjects who are assigned to either the High Risk Favorable (HR-Fav) B-ALL or High Risk (HR) B-ALL risk group at the end of Part 1: The overall goals of this study are to determine (1) in subjects with HR B-ALL, whether adding inotuzumab ozogamicin (InO) to standard of care chemotherapy maintains or improves outcomes; (2) in subjects with HR B-ALL, whether treating both males and females with the same duration of chemotherapy (2 years from the start of INterim Maintenance) maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance; (3) in subjects with HR-Fav, to describe outcomes for patients when treated with one phase of Interim Maintenance instead of two, and when treating both males and females with the same duration of chemotherapy (2 years from the start of Interim Maintenance).

This study is currently enrolling.