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

Recruiting

• Conditions: Central Nervous System Lymphoma; Diffuse Large B-Cell Lymphoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06031194
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2023-05-10
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance	Up to 24 weeks	Determine the SNPs associated with delayed methotrexate clearance

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States