What is the role of blinatumomab (Blincyto) in the treatment of relapsed pediatric acute lymphoblastic leukemia (ALL)?

Updated: Jan 03, 2019
  • Author: Vikramjit S Kanwar, MBBS, MBA, MRCP(UK), FAAP; Chief Editor: Jennifer Reikes Willert, MD  more...
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Answer

Blinatumomab (Blincyto) was approved in December 2014 for adults with Ph- relapsed or refractory B-precursor ALL. Data are emerging for pediatric patients. The prescribing information describes a dose-escalation study of 41 pediatric patients with relapsed or refractory B-precursor ALL (median age was 6 yr [range: 2-17 yr]) with doses ranging from 5-30 mcg/m2/day. [25]

In a phase 2 study of pediatric patients who relapsed following bone marrow transplant, Schelegel et al recommended a dosage regimen of 5 mcg/m2/day on Days 1-7 and 15 mcg/m2/day on Days 8-28 for cycle 1, and 15 mcg/m2/day on Days 1-28 for subsequent cycles. [26]

At a higher dose, a fatal cardiac failure event was described in the setting of life-threatening cytokine release syndrome. [25] The steady-state concentrations of blinatumomab were comparable in adult and pediatric patients at the equivalent dose levels based on body surface area (BSA)-based regimens. [25]


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