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The low-intensity chemotherapy regimen (Amgen) is a multi-agent cytotoxic combination protocol specifically designed for use in the Phase 3 Golden Gate clinical trial (NCT04485585). This regimen is intended for older adults (aged 55 and older) with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (ALL). It serves as a reduced-intensity backbone to be alternated with the bispecific T-cell engager blinatumomab (Blincyto). The regimen typically consists of lower-dose versions of standard induction and consolidation agents, including cyclophosphamide, vincristine, dexamethasone, and methotrexate, along with intrathecal prophylaxis (e.g., cytarabine or methotrexate). The goal of this low-intensity approach is to maintain anti-leukemic efficacy while significantly reducing the treatment-related mortality and severe toxicities associated with intensive "high-intensity" chemotherapy in the elderly population.
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