Therapeutic Drug Monitoring

The Therapeutic Drug Monitoring team is dedicated to advancing drug monitoring (TDM) and associated research for Acute Lymphoblastic Leukemia (ALL). Through a unique integration of clinical pharmacology, immunology, metabolomics, and analytical assay development, our current work aims to optimize L-asparaginase therapy, reduce treatment-related toxicities, and improve outcomes for children undergoing Leukemia treatment.

Our achievements

• Establishment of L-Asparaginase drug monitoring platform in Paediatric Acute Lymphoblastic Leukaemia (ALL).

• Anti-Asparaginase Antibody research to identify drug related immunogenicity.

• Development of novel Glutaminase Activity Assay

• Amino Acid Depletion study in collaboration with Sciex corporation, India

Our Objectivess

• Optimize asparaginase therapy through therapeutic drug monitoring and personalized treatment approaches in paediatric ALL.

• Understand treatment variability by studying drug activity, immunogenicity, resistance mechanisms, and toxicity profiles.

• Develop innovative diagnostic assays and biomarkers for monitoring treatment efficacy and safety.

• Translate multi-dimensional clinical and laboratory data into precision medicine strategies that improve outcomes for children with leukaemia.

• Propagation of multi-centre drug monitoring across India to evaluate quality and provide a better and safer treatment regimen.

Ongoing Studies and Clinical Trials

• TTCRC-Gennova Collaborative Studies

• To assess safety of Hamsyl® in a phase-IV clinical study for the treatment of newly diagnosed patients of acute lymphoblastic leukaemia (ALL), GBL/PEGASP/ALL/2020/01

• A Multicenter PK/PD study of Hamsyl®/Hamsyl® Jr. in patients with newly diagnosed Acute Lymphoblastic Leukemia (ALL), post induction

Upcoming Events

• Workshop and hands-on training for Clinical members for establishment of TDM platform in LMICs outside India in association with Act ForChildren, an international organization for access to cancer care in children.

Recent publication

• Neerajana Datta, Bishwaranjan Jana, Srijani Goswami, AnnweshaRoy, SamikSamaddar, Subhajit Kundu, ManashPratimGogoi, Bony Dasgupta, Trina Dutta, Nandana Das, VaskarSaha, Jasmeet Sidhu, Shekhar Krishnan: Biogeneric native and polyethylene glycol-conjugated E. coli asparaginases for treating children with acute lymphoblastic leukemia 2026; Therapeutic Drug Monitoring,DOI: 10.1097/FTD.0000000000001473