Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
Recruiting now
Conditions studied: ALL, Childhood, Pediatric Cancer, Toxicity, Drug, Adverse Drug Event, Relapse Leukemia, Drug Toxicity, Drug Effect, Drug Interaction
In brief
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.
Key facts
- Study ID
- NCT05512169
- Run by
- University of Geneva, Switzerland
- People needed
- 556
- Starts
- 2022-12-01
- Expected to finish
- 2027-03-30
- Last updated by the study team
- 2026-01-15
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Previously tretaed patients
- Patients with Down's syndrome
- Patients with mature B-ALL
Where it is running
- Dr. Sameer Bakhshi — New Delhi, India (enrolling)
- Dr. Biswajit Dubashi — Puducherry, India (enrolling)
Full record on ClinicalTrials.gov
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