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March 29, 2026Pediatric Blood & Cancer0 citationsOpen Access

CPX‐351 in High‐Risk Relapsed Pediatric Acute Leukemia: Real‐World Phase 1 Data Establishing the FDA‐Approved Dose

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JBJonathan BenderLPLauren PommertLBLori R. Backus

Key Points

  • To evaluate the safety and efficacy of cpx-351 at the FDA-approved dose in pediatric patients with relapsed acute leukemia.
  • Real-world phase 1 study design
  • Administration of cpx-351 at a dose of 44 mg/m² daunorubicin
  • Evaluation of safety and treatment activity in children with R/R acute leukemia
  • Cpx-351 was found to be safe and tolerable in the pediatric population
  • The treatment demonstrated promising activity in high-risk acute myeloid leukemia (AML)
  • Establishment of the FDA-approved dose for specific AML subtypes

Abstract

CPX-351 at 44 mg/m2 daunorubicin/dose was safe and tolerable in children with R/R acute leukemia, showing promising activity in heavily pretreated, high-risk AML and is now the FDA-approved pediatric dose for therapy-related AML or AML with myelodysplastic changes.

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Cite This Study

Bender et al. (2026) studied this question.

synapsesocial.com/papers/69c8c30dde0f0f753b39da35https://doi.org/10.1002/1545-5017.70268
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