High Dose Methotrexate Pharmacokinetics, Pharmacogenomics, Adverse Effects and Clinical Outcomes in Patients with Acute Lymphoblastic Leukaemia
Not Applicable
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2023/07/054865
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Patients who are on oral Methotrexate
Patients who are not on regular follow up
Not willing to give consent for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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