A Pilot Study Conducted at a Tertiary Cancer Care Center, Evaluating the Serum Asparaginase Activity in Children Suffering from Acute Lymphoblastic Leukemia after the Administration of Biosimilar Pegaspargase

Abstract Introduction L-asparaginase is considered to be the most important component in treatment of acute lymphoblastic leukemia (ALL). Intensifying use during for ALL has resulted a significant rise percentage children and adolescents who are cured disease. Asparaginase trough activity more than or equal 100 IU/L on day 7 been found desired level all childhood patients. Objectives Due paucity data biosimilar pegaspargase upfront setting, we planned this prospective pilot study evaluate levels serum asparaginase (SAA) after infusion. Materials Methods It prospective, single-center, 10 pediatric patients duration 6 months. All less 18 years with curative intent receiving provided informed consent were included study. The enzymatic spectrophotometric method was used determine SAA, it measured 7th 14th days first dosage pegaspargase-asparaginase, as well second dose while toxicity charted according Common Terminology Criteria Adverse Events (CTCAE) version 4.0. Results From median age 5.5 years, grand total 29 samples taken analysis. Children received had either B-ALL T-ALL. After dose, mean ± SD (standard deviation), SAA at 131.3 38 Day 14 94.8 8 IU/L. 86.1 15 No patient clinical hypersensitivity reaction no reported any asparaginase-related toxicity. One died due sepsis, infection multidrug-resistant gram-negative bacteria. Conclusions Biosimilar maintained good Drug Trial Registration: Clinical Registry India vide reference CTRI/2021/08/036033 available https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59285&EncHid=&userName=