NCT05512169Recruiting
Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 556 (estimated)
- First submitted
- 20 Jun 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- University of Geneva, Switzerland
- NCT number
- NCT05512169
What you commit to
- Study type: Observational
- Planned participants: 556
- From 1 Dec 2022 to the primary completion date, 30 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously tretaed patients
Other illness
- Patients with Down's syndrome
Other
- Patients with mature B-ALL
Who the study is looking for
- 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
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Sameer Bakhshi Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
| Dr. Biswajit Dubashi Coordinator of this site? Confirm its status | Puducherry | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.