Effects of genetics on methotrexate clearance in lymphoma patients
Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
This study is trying to see how genetic differences affect how well lymphoma patients clear high doses of methotrexate and if these differences lead to more side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06031194 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates how genetic variations affect the clearance of high-dose methotrexate in patients diagnosed with diffuse large B-cell lymphoma or primary central nervous system lymphoma. The primary objectives include identifying single nucleotide polymorphisms (SNPs) associated with delayed methotrexate clearance and exploring any links between these SNPs and increased toxicity. Participants will provide blood samples and have their medical records reviewed to gather relevant data. The study aims to enhance understanding of pharmacogenomics in cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with diffuse large B-cell lymphoma or primary central nervous system lymphoma who are scheduled to receive high-dose methotrexate.
Not a fit: Patients with currently active second malignancies or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment approaches that optimize methotrexate dosing and reduce toxicity for lymphoma patients.
How similar studies have performed: Other studies have shown promise in pharmacogenomic approaches to cancer treatment, suggesting potential for success in this area.
Eligibility criteria
Show full 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Timothy Voorhees, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.