Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)

What this Trial Is About

Researchers are conducting a five-year prospective observational study focused on Indian children aged 1 to 18 years with acute lymphoblastic leukemia (ALL). The study aims to explore how static germline genetic variants relate to early chemotherapy-related toxicities and how somatic genetic markers influence steroid treatment response during the standard IciCLe-ALL-14 treatment protocol. This international collaboration involves centers in India and Switzerland, with patient recruitment taking place exclusively at two Indian centers. The study has two phases: the first investigates genetic predispositions to treatment toxicities using whole-exome sequencing and candidate gene analysis, while the second phase focuses on genotyping selected genetic variants to assess their association with treatment outcomes. Biological samples including saliva, blood, bone marrow, and plasma will be collected and stored for genetic and protein marker analysis. Routine therapeutic drug monitoring will also be performed to correlate drug levels with genetic markers and clinical outcomes. Participants will be closely followed, with clinical data such as demographics, disease classification, minimal residual disease, toxicity, and survival outcomes recorded electronically. Quality of life will be assessed using the Pediatric Quality of Life Inventory at diagnosis and during maintenance therapy. The study will monitor early treatment-related toxicities graded by standard criteria, disease response at specific treatment timepoints, and long-term outcomes including relapse and overall survival over a minimum of one year, with further analysis planned at five years post-treatment.

Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia