AALL1621: A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518 IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)
Brief description of study
Despite the advances made with intensive and risk-stratified treatment regimens, 10-20%of children and adolescents with ALL will relapse, and outcomes for those with relapseddisease remain poor despite the use of intensive chemotherapy regimens and HSCT.1-3.Efforts to further escalate the intensity of chemotherapy regimens are limited by toxicity,and targeted agents with novel mechanisms of action are needed to improve outcomes notonly for patients with relapse, but also for newly diagnosed patients with a high risk ofrelapse. This phase 2 single-agent trial will evaluate the adult RP2D of InO (1.8 mg/m2/cycleadministered on a fractionated schedule on day 1, 8, 15 of a 28-day cycle) in pediatricpatients with relapsed or refractory CD22-positive B-ALL. The goal of this study is todocument the toxicity profile of this agent in a pediatric population, as well as determineits efficacy in the relapsed or refractory setting. This safety and efficacy data will lay thefoundation for the incorporation of InO treatment blocks in a randomized fashion intofrontline trials for newly diagnosed high-risk patients
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