Authors
Maureen Megan O'Brien, Jennifer Lynn McNeer, Susan R Rheingold, Meenakshi Devidas, Zhiguo Chen, Deepa Bhojwani, Laura B Ramsey, Anurag Agrawal, Brent L Wood, Eugene Suh, Sarah Alexander, Tamara P Miller, Olga Militano, Michael Burke, Wanda L Salzer, Elizabeth A Raetz, Mignon L Loh
Publication date
2023/6/1
Source
Journal of Clinical Oncology
Volume
41
Issue
16_suppl
Pages
10016-10016
Publisher
American Society of Clinical Oncology
Description
10016
Background: Inotuzumab ozogamicin (InO) is effective in adults and children with relapsed/refractory (R/R) CD22+ B-acute lymphoblastic leukemia (B-ALL). Children’s Oncology Group AALL1732 is a phase 3 randomized trial evaluating InO for newly diagnosed patients (pts) with high-risk B-ALL. Given known hepatic, hematologic, and infectious toxicities, two safety phases were completed. Methods: Pts with residual marrow disease < 0.01% by end consolidation are randomized to chemotherapy (Arm A) or chemotherapy plus 2 cycles of InO (Arm B) after consolidation and interim maintenance 1 (IM1). Modifications after safety phase 1 [SP1; McNeer et al. Blood (2021) 138 (Suppl 1):3398] included reducing InO to 1.2mg/m2/cycle, increasing hydration during IM1 on Arm B, and enhancing supportive care in delayed intensification (DI) with antimicrobials. Safety phase 2 (SP2) assessed methotrexate (MTX …
Total citations
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