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)

Brief description of study

While outcomes in SR B-ALL have improved significantly, this population still accounts for approximately half of the overall burden of relapse among children with ALL. Combining traditional prognosticators with new MRD detection technologies, this trial will identify subsets of SR children with outstanding outcomes in whom no new therapeutic randomized intervention will be tested. The remainder of patients, with expected inferior outcomes, will be randomized to receive or not receive a promising new immunotherapy, blinatumomab, in an effort to improve DFS. We will also investigate the role of immunotherapy in children with DS and B-ALL, a population traditionally excluded from studies of novel agents, and for which intensification of standard cytotoxic chemotherapy is impossible due to their significantly increased risk of non-relapse morbidity and mortality. At the completion of this frontline trial, we envision that an improved risk stratification and treatment approach for all children with ALL will be established incorporating the most effective elements of conventional and novel therapy and emerging diagnostic tools, such as MRD detection using DNA based HTS. If successful, this could also pave the way for replacing the most toxic elements of therapy with immunotherapy in the future. Finally, this trial will also confirm that patients can be treated with a uniform duration of therapy (2 years from the start of Interim Maintenance I) regardless of sex, substantially reducing the burden of therapy for males.

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