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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06031194
Other study ID # OSU-22305
Secondary ID NCI-2023-03467
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2023
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Non-Interventional Study
Non-interventional study

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance Determine the SNPs associated with delayed methotrexate clearance Up to 24 weeks
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