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21-037 - AALL1821 - A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Status: open

AALL1821 - A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC# 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to <31 Years Old with First Relapse

Treatment for Pediatric Oncology- B-ALL

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Description

To compare rate of minimal residual disease (MRD) negative second remission after up to two cycles of Reinduction with blinatumomab vs. blinatumomab/nivolumab in Group 1 patients aged ≥ 1 to < 31 years old with first relapse of CD19+ B-ALL. To compare EFSPI (EFS post-Induction) between Consolidation with blinatumomab vs. blinatumomab/nivolumab in Group 3 patients aged ≥ 1 to <31 years old with first relapse of CD19+ B-ALL.

Sponsors

This trial is sponsored by Children's Oncology Group.

Providers Associated With This Trial

Principle Investigator

Sub Investigators

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