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This combination therapy regimen consists of calaspargase pegol (Asparlas) and the Hyper-CVAD multi-agent chemotherapy protocol. Calaspargase pegol is a pegylated recombinant E. coli-derived L-asparaginase enzyme that functions by depleting circulating L-asparagine, an amino acid essential for the survival of leukemic lymphoblasts which lack asparagine synthetase. The Hyper-CVAD component is an intensive chemotherapy regimen involving alternating cycles (Course A and Course B). Course A includes hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone, while Course B consists of high-dose methotrexate and cytarabine. This specific combination is being investigated by the H. Lee Moffitt Cancer Center and Research Institute in a Phase 1b study to evaluate its safety and efficacy in young adults (up to age 50) with newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). Rituximab may also be included for patients with CD20-positive disease.
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