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Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma

Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06031194
Enrollment
20
Registered
2023-09-11
Start date
2023-05-10
Completion date
2025-12-23
Last updated
2026-01-06

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

Conditions

Central Nervous System Lymphoma, Diffuse Large B-Cell Lymphoma

Brief summary

This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To identify SNPs associated with delayed MTX clearance. II. To explore any association between SNPs and increased toxicity. OUTLINE: This is an observational study. Participants undergo blood sample collection and have their medical records reviewed on study.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \* Adult (age ≥ 18 years at diagnosis) * Diagnosis of DLBCL or PCNSL * Planned to undergo treatment with HDMTX (≥ 3 g/m\^2) at the James Cancer Hospital. Note: patients with CKD are eligible to participate regardless of eGFR provided the treating physician is planning a dose of HDMTX of at least 3 g/ m\^2. * Ability to provide informed consent.

Exclusion criteria

* \* Patients with a currently active second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation * Pregnancy (positive serum or urine pregnancy test), lactating or breast feeding * Prisoners or incarcerated patients * Total bilirubin \> 5 mg/dL

Design outcomes

Primary

MeasureTime frameDescription
SNPs (single nucleotide polymorphisms) associated with delayed MTX clearanceUp to 24 weeksDetermine the SNPs associated with delayed methotrexate clearance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026