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

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