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Identification of unfavorable or unintended sign, symptom, or disease temporally associated with the use of high dose methotrexate in children with cancer

Therapeutic safety assessment of high-dose methotrexate in pediatric hematolymphoid malignancies: an ambispective study - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/089433
Enrollment
103
Registered
2025-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Manipal academy of higher education
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients under 18 years 2. Diagnosed with Hematolymphoid malignancy 3. Prescribed with HDMTX regimen.

Exclusion criteria

Exclusion criteria: 1. Solid tumors and other hematological conditions 2. Not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
The frequency of adverse events throughout the HDMTX regimen will be identified, and the most and least occurring AE will be reported.Timepoint: Data collection will be carried out following the administration of high-dose methotrexate (HDMTX), specifically at the 24th and 42nd hours post-administration.

Secondary

MeasureTime frame
The relationship between serum MTX level and different patient, treatment, and disease-related characteristics, including the occurrence of AE, will be identified.Timepoint: during the period of 24 th hour and till discharge after drug administration;The disproportionality analysis will identify the new signals for MTX in the population.Timepoint: single time point

Countries

India

Contacts

Public ContactRajesh V

Kasturba medical college

vasudev.bhat@manipal.edu9619114703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026