Studies genetic markers linked to treatment side effects in children with leukemia
Observes whether inherited gene variants relate to side effects in children with leukemia.
Plain-language title generated from the registry record
Registry title: Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
Key facts
- Where
- New Delhi and Puducherry, IndiaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 18 years old?
Source: NCT05512169, who can take part
Where in India
- Dr. Sameer BakhshiNew Delhi, IndiaTaking people
- Dr. Biswajit DubashiPuducherry, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Geneva, Switzerland
- Trial code
- NCT05512169
- Record updated
- 15 January 2026
- Original description
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.Read full original descriptionShow less
Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)
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.
Inclusion: 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: Previously tretaed patients; Patients with Down's syndrome; Patients with mature B-ALL.