Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance
研究概览
简要总结
This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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^
- •Ability to provide informed consent.
排除标准
- •* 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
研究组 & 干预措施
Observational
Participants undergo blood sample collection and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
SNPs (single nucleotide polymorphisms) associated with delayed MTX clearance
时间窗: Up to 24 weeks
Determine the SNPs associated with delayed methotrexate clearance
次要结局
未报告次要终点
研究者
Timothy Voorhees
Principal Investigator
Ohio State University Comprehensive Cancer Center