Observing genetic factors in Indian children with leukemia
Official title: Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)
Run by University of Geneva, Switzerland · NCT05512169 · Data updated 2026-11-12
This study looks at how genetic differences might affect side effects from chemotherapy in Indian children with leukemia to see how it impacts their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year to 18 Years |
| Sex | All |
| Enrollment | 556 (estimated) |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 2 sites (New Delhi and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2022 |
| Main results expected | March 30, 2027 |
| Study ends | March 30, 2027 |
| Registry record updated | January 15, 2026 |
| Trial ID | NCT05512169 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Indian children aged 1 to 18 years who are newly diagnosed with ALL and meet the IciCle treatment protocol criteria.
✕Probably not a fit
Patients who have previously received treatment for ALL or have Down's syndrome or mature B-ALL may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study aims to explore the relationship between genetic variants and chemotherapy-related toxicities in Indian children diagnosed with acute lymphoblastic leukemia (ALL). Conducted over five years, it involves collaboration between centers in Switzerland and India, focusing on both germline and somatic genetic markers. The study will also assess the impact of early toxicities on the quality of life of participants and aims to biobank samples for future research. Data will be meticulously collected and monitored to ensure accuracy and confidentiality.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that minimize toxicities and improve outcomes for children with ALL.
How similar studies have gone: While pharmacogenomic studies have shown promise in other populations, this specific approach in Indian children with ALL is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dr. Sameer Bakhshi
New Delhi, India Recruiting -
Dr. Biswajit Dubashi
Puducherry, India Recruiting
Study contacts
- Principal investigator: Chakradhara Rao S UPPUGUNDURI — University of Geneva, Switzerland
- Study coordinator: Chakradhara Rao S Uppugudnuri
- Email: chakradhara.uppugunduri@unige.ch
- Phone: +41223794685
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.