19-452 - AALL1732 - Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Status: open

AALL1731 A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

Treatment for Pediatric Oncology- Localized B-Lymphoblastic Lymphoma (B-LLy)

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Description

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The goal of the part 1 of the study is to collect information about leukemia and the effects of the first two phases of treatment, called Induction and Consolidation on this cancer. Additionally, this study aims to investigate whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance in patient with High Risk Favorable (HR-Fav) and HR B-ALL. Another aim is to understand the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) receiving HR B-ALL therapy. Finally, another goal of this study is to determine the outcomes of subjects with Mixed Phenotype Acute Leukemia (MPAL) with a favorable early response to treatment using High Risk B-cell Acute Lymphoblastic Leukemia therapy.

Sponsors

This trial is sponsored by Children's Oncology Group.

Providers Associated With This Trial

Principle Investigator

Sub Investigators

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