Trial Number

975-19

Condition

Leukemia

Participant Age Range

1 year to 31 years

Participant Gender

Any

Enrolling Participants

Yes

Overview

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)

While outcomes in Standard Risk (SR) B-lymphoblastic leukemia (B-ALL) have improved significantly, this population still accounts for approximately half of the overall burden of relapse among children with ALL. Despite contemporary intensive chemotherapy, the outcomes for children with relapsed ALL remain dismal, with 5-year overall survival (OS) of approximately 38%. Interventions that further reduce the number of SR ALL relapses will therefore significantly improve the long-term survival of the overall ALL population. AALL1731 is a group-wide risk-stratified trial for children with newly diagnosed B-ALL and localized B-lymphoblastic lymphoma (B-LLy) that will test if the addition of blinatumomab to standard chemotherapy in patients with NCI SR B-ALL at highest risk for relapse will improve disease-free survival (DFS).

Provider

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