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)
Categories (click each to see list of all clinical trials associated with that category): CTO Pediatric Trials (ONC), Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Eligibility: https://clinicaltrials.gov/study/NCT03914625?term=NCT03914625&rank=1
Summary
To determine in a randomized manner if the addition of 2 cycles of blinatumomab to standard therapy improves disease-free survival (DFS) in patients with SR B-ALL and higher risk features (SR-High), and patients with standard-risk average (SR-Avg) B-ALL who are negative for minimal residual disease (MRD) by flow cytometry but have detectable or indeterminate MRD as measured by high-throughput sequencing (HTS) at end of Induction (EOI). To confirm that boys in the standard-risk favorable (SR-Fav) subset of B-ALL, with or without DS, will maintain a 5-year DFS of greater than 93% when treated with a standard chemotherapy regimen with a treatment duration of 2 years from the start of Interim Maintenance I (IM1).