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Influence of genetic modification on toxicities of Methotrexate in children with Leukemia

Association of Genetic Polymorphism with Toxicities of High Dose Methotrexate in Children with Acute Lymphoblastic Leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/07/043817
Enrollment
132
Registered
2022-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Control Intervention1: NIL: NIL

Sponsors

Sri Ramachandra Institute of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pediatric patients diagnosed with Acute Lymphoblastic Leukemia 2. Both male and female patients between the age group of 0 -18 years 3. Patients who are categorized as high-risk, intermediate-risk, and relapse based on the protocol 4. Patients who are being prescribed Intravenous (I.V) Methotrexate (500mg/m2-5gm/m2)

Exclusion criteria

Exclusion criteria: 1. Patients with other types of malignancies 2. Patients who are being prescribed oral Methotrexate

Design outcomes

Primary

MeasureTime frame
The study will predict the genetic variant gene responsible for the development of methotrexate-induced toxicity in ALL patients, which will be useful in tailoring the doses of Methotrexate for this population.Timepoint: After 24 hrs of methotrexate administration genetic analysis will be carried out

Secondary

MeasureTime frame
Serum concentration leading to Methotrexate induced toxicities will be identifiedTimepoint: Patients serum concentration will be estimated at baseline, after 24 and 48 hrs after Methotrexate administration

Countries

India

Contacts

Public ContactDr Vanitha Rani N

Sri Ramachandra Institute of higher education and Research

jxscott@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026