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

NCT06031194 | Completed

• 2 other identifiers: OSU-22305NCI-2023-03467
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B-Cell Lymphoma; Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (1)

• SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance

  Determine the SNPs associated with delayed methotrexate clearance

  Up to 24 weeks

Study Arms (1)

Observational

Participants undergo blood sample collection and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with DLBCL or primary CNS lymphoma planned to undergo treatment with HDMTX (≥ 3 g/m\^2) at the James Cancer Hospital

You may qualify if:

• \* 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.

You may not qualify if:

• \* 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Timothy Voorhees, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 11, 2023
• Study Start: May 10, 2023
• Primary Completion: November 5, 2025
• Study Completion: December 23, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)