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OpenTrials
Completed

NCT Number: NCT06031194

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance

    Time frame: Up to 24 weeks

    Determine the SNPs associated with delayed methotrexate clearance

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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