Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia

A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva. The study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.

NCT Number	NCT05512169
Lead Sponsor	University of Geneva, Switzerland Collaborators: Jawaharlal Institute of Postgraduate Medical Education & Research, All India Institute of Medical Sciences, Swiss National Science Foundation, Ministry of Science and Technology, India, CANSEARCH Foundation
Conditions	ALL, Childhood, Pediatric Cancer, Toxicity, Drug, Adverse Drug Event, Relapse Leukemia, Drug Toxicity, Drug Effect, Drug Interaction
Enrollment	556 participants
Start Date	2022-12-01
Primary Completion	2027-03-30 (estimated)
Study Completion	2027-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-15