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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06031194
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ohio State University Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Narendranath Epperla, MD, MS
Principal Investigator Affiliation Ohio State University Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Central Nervous System Lymphoma, Diffuse Large B-Cell Lymphoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: Observational

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

Interventions

Other: - Non-Interventional Study

Non-interventional study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbus, Ohio

Status

Recruiting

Address

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Site Contact

Narendranath Epperla, MD, MS

[email protected]

614-688-7940

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