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

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