Central Nervous System LymphomaNCT06031194
Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
An observational study of Central Nervous System Lymphoma and Diffuse Large B-Cell Lymphoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Lymphoma, Diffuse Large B-Cell Lymphoma
- What is being tested?
- Non-Interventional Study
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 23 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with DLBCL or primary CNS lymphoma planned to undergo treatment with HDMTX (≥ 3 g/m^2) at the James Cancer Hospital
Who may be able to join
- * 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.
Who cannot join
- * 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 locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Non-Interventional Study
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants undergo blood sample collection and have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance
Determine the SNPs associated with delayed methotrexate clearance
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start10 May 2023
- Primary completion5 Nov 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Voorhees, Ohio State University Comprehensive Cancer Center
- Investigators
- Timothy Voorhees, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031194
- Sponsor's protocol ID
- OSU-22305
- Other IDs
- NCI-2023-03467
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06031194
- Acronym / sponsor ID
- OSU-22305
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma.
Detailed description
PRIMARY OBJECTIVES:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyParticipants undergo blood sample collection and have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with DLBCL or primary CNS lymphoma planned to undergo treatment with HDMTX (≥ 3 g/m^2) at the James Cancer Hospital
Key inclusion criteria (5 listed)
- * Adult (age ≥ 18 years at diagnosis)
- 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.
Key exclusion criteria (4 listed)
- * Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance
Time frame: Up to 24 weeks
Determine the SNPs associated with delayed methotrexate clearance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Voorhees, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Lymphoma and Diffuse Large B-Cell Lymphoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.