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High Dose Methotrexate Pharmacokinetics, Pharmacogenomics, Adverse Effects and Clinical Outcomes in Patients with Acute Lymphoblastic Leukaemia

A Pilot Study to Determine the Influence of Single Nucleotide Polymorphism on High Dose Methotrexate Pharmacokinetics, Adverse Effects and Clinical Outcomes in Patients with Acute Lymphoblastic Leukaemia in a North Indian Tertiary Care Hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054865
Enrollment
100
Registered
2023-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Intervention1: Methotrexate: 2 ml Blood will be collected at 3 time points in each maintenance cycle who are on high dose methotrexate

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with Acute Lymphoblastic Leukaemia who are receiving intravenous infusion of high dose methotrexate (HDMTX) with a dose of 3 - 5 g / m2

Exclusion criteria

Exclusion criteria: Patients who are on oral Methotrexate Patients who are not on regular follow up Not willing to give consent for the study

Design outcomes

Primary

MeasureTime frame
Aallele frequencies for Genotypes of MTHFR C677T, TYMS rs34743033 tandem repeat polymorphism, SLCO1B1 rs10841753, and SLCA119A in patients with acute lymphoblastic leukemia (ALL) in the north Indian populationTimepoint: At Baseline—

Secondary

MeasureTime frame
correlation of methotrexate levels with clinical outcomes in ALL patientsTimepoint: 60 days;correlation of genetic polymorphism of MTHFR C677T, TYMS rs34743033 tandem repeat polymorphism, SLCO1B1 rs10841753 & SLCA119A with clinical outcomes in ALL patientsTimepoint: baseline 15 days 30 days 45 days & 60 days;correlation of genetic polymorphism of MTHFR C677T, TYMS rs34743033 tandem repeat polymorphism, SLCO1B1 rs10841753 & SLCA119A with adverse events of high dose methotrexate in ALL patientsTimepoint: baseline 15 days 30 days 45 days & 60 days;correlation of genetic polymorphism of MTHFR C677T, TYMS rs34743033 tandem repeat polymorphism, SLCO1B1 rs10841753, & SLCA119A with plasma methotrexate levels in ALL patientsTimepoint: baseline 15 days 30 days 45 days & 60 days—

Countries

India

Contacts

Public ContactDr Lekha Saha

PGIMER, Chandigarh

lekhasaha@rediffmail.com919463503752

Outcome results

None listed

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