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

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The Ohio State University

Status

Enrolling

Conditions

Diffuse Large B-Cell Lymphoma
Central Nervous System Lymphoma

Treatments

Other: Non-Interventional Study

Study type

Observational

Funder types

Other

Identifiers

NCT06031194
NCI-2023-03467 (Registry Identifier)
OSU-22305

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Observational
Description:
Participants undergo blood sample collection and have their medical records reviewed on study.
Treatment:
Other: Non-Interventional Study

Trial contacts and locations

1

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Central trial contact

The Ohio State Comprehensive Cancer Center

Data sourced from clinicaltrials.gov

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