Observing genetic factors in Indian children with leukemia
Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)
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 |
|---|---|
| Enrollment | 556 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 2 sites (New Delhi and 1 other locations) |
| Trial ID | NCT05512169 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While pharmacogenomic studies have shown promise in other populations, this specific approach in Indian children with ALL is relatively novel.
Eligibility criteria
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 this trial is running
New Delhi and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.