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Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia

NCT05512169 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 556

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

  • ALL, Childhood
  • Pediatric Cancer
  • Toxicity, Drug
  • Adverse Drug Event
  • Relapse Leukemia
  • Drug Toxicity
  • Drug Effect
  • Drug Interaction

Sponsors & Collaborators

  • Jawaharlal Institute of Postgraduate Medical Education & Research

    collaborator OTHER_GOV

  • All India Institute of Medical Sciences

    collaborator OTHER

  • Swiss National Science Foundation

    collaborator OTHER

  • Ministry of Science and Technology, India

    collaborator OTHER_GOV

  • CANSEARCH Foundation

    collaborator UNKNOWN

  • University of Geneva, Switzerland

    lead OTHER

Principal Investigators

  • Chakradhara Rao S UPPUGUNDURI · University of Geneva

  • Biswajit DUBASHI · Jawaharlal Institute of Postgraduate Medical Education & Research

  • Sameer BAKHSHI · All India Instiutte of Medical Scineces

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2027-03-30
Completion
2027-03-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512169 on ClinicalTrials.gov