Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Drug Event | — | UNRESOLVED | — |
| ALL, Childhood | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Drug Effect | — | UNRESOLVED | — |
| Drug Interaction | — | UNRESOLVED | — |
| Drug Toxicity | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Relapse Leukemia | — | UNRESOLVED | — |
| Toxicity, Drug | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Newly diagnosed ALL Children with age group of >1 and ≤18 years old
- description
- Newly diagnosed ALL Children who are likely to receive anti-cancer drugs or chemotherapy as a part of IciCLE treatment protocol.
Primary outcomes (3)
- measure
- Cumulative incidences of early treatment related adverse events as assessed by CTCAE v5.0
- timeFrame
- 10-12 months varying depnding upon the risk category
- description
- Drug-related toxicity ≥ grade 3 occurring from the first day of induction until the middle of maintenance therapy. Cumulative incidences of neutropenia from day 1 of maintenance to day 100 of maintenance therapy. Incidences of multiple drug related adverse events of grade 3 and above as assessed by CTCAE v5.0 before day 100 of maintenance phase. Incidences of 14 severe acute toxic effects as defined by Ponte di Legno toxicity working group consensus definitions (Ref: Lancet Oncol 2016;17:e231-e239) Drug causality for the adverse event and grade at onset , maximum grade, and date of resolution will be considered. Assessment of biochemical tests to consider for toxicity assessment as per CTCAE criteria will be performed every week until the maintenance phase, and then once in two weeks from day 1 to day 100 of maintenance phase.
- measure
- Disease response to the treatment during induction phase to steroids
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDChenchula S, Atal S, Uppugunduri CRS. A review of real-world evidence on preemptive pharmacogenomic testing for preventing adverse drug reactions: a reality for future health care. Pharmacogenomics J. 2024 Mar 15;24(2):9. doi: 10.1038/s41397-024-00326-1. PMID 38490995
- RESULTKodidela S, Dorababu P, Thakkar DN, Dubashi B, Sundaram R, Muralidharan N, Nidanapu RP, Aribandi A, Pradhan SC, Uppugunduri CRS. Association of NUDT15*3 and FPGS 2572C>T Variants with the Risk of Early Hematologic Toxicity During 6-MP and Low-Dose Methotrexate-Based Maintenance Therapy in Indian Patients with Acute Lymphoblastic Leukemia. Genes (Basel). 2020 May 28;11(6):594. doi: 10.3390/genes11060594. PMID 32481505