Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
This study looks at how a child's genes affect how well they respond to leukemia treatment. Researchers will follow Indian children with acute lymphoblastic leukemia (ALL) for five years to understand the connection between their genetic makeup and how their cancer responds to therapy.
Key Objective: This research may help doctors better predict which children will respond best to specific ALL treatments based on their genetic profile.
Who to Consider: Indian children newly diagnosed with acute lymphoblastic leukemia who are interested in contributing to research that could improve treatment outcomes for future patients should consider enrolling.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age \> 1 year old and ≤18 years old at enrolment * Previously untreated * ALL diagnosis confirmed by morphology and flow-cytometry * Indian origins * Fulfilling IciCle treatment protocol inclusion criteria and receiving treatment as per the protocol * Written Informed consent to participate in the study has to be signed by the participant/parent/guardian Exclusion Criteria: * Previously tretaed patients * Patients with Down's syndrome * Patients with mature B-ALL