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

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06031194
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 19.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Central Nervous System Lymphoma; Diffuse Large B-Cell Lymphoma	Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

1. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
• Actual Study Start Date: May 10, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Observational Participants undergo blood sample collection and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-interventional study

Outcome Measures

Primary Outcome Measures

1. SNPs associated with delayed MTX clearance [Up to 24 weeks]

   Determine the SNPs associated with delayed methotrexate clearance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Narendranath Epperla, MD, MS, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The Jamesline

Publications

None provided.

• Responsible Party: Narendranath Epperla, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT06031194
• Other Study ID Numbers: OSU-22305; NCI-2023-03467
• First Posted: Sep 11, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of Sep 11, 2023