Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Composite of Treatment Patterns
研究概览
简要总结
The purpose of this study is to gather data on patients diagnosed with and treated for classical Hodgkin Lymphoma (cHL). It aims to closely observe how treatment for cHL is rendered, as well as assess the outcome of those treatment options and their impact on quality of life. Additional analyses will also attempt to identify prognostic or predictive biomarkers
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
- •Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
- •Patients must be within ± 2 weeks of Day 1 of the first cycle of any line of therapy to enroll; a cycle is practice-defined for chemotherapy, targeted therapy, or immunotherapy-based regimens.
- •Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
- •Patients must have available medical records for the date of diagnosis of cHL and available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anti-cancer therapy received.
- •Patients must consent for use of their FFPE tissue blocks for exploratory analyses
排除标准
- •Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
- •Patients with unknown date of diagnosis of cHL
- •Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
- •Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
- •Patients participating in a clinical study that does not allow enrollment into a non-interventional study
- •Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Composite of Treatment Patterns
时间窗: Up to five years
What are the treatment patterns of therapies used to treat cHL (ie, incorporation of novel chemotherapy or non-chemotherapy to upfront therapy, chemotherapy/radiation and/or transplant sparring patterns, incorporation of immune checkpoint agents or other investigational therapies)
Duration of Response
时间窗: Up to five years
Overall Survival (OS)
时间窗: Up to five years
Percentage of patients who achieve complete response
时间窗: Up to 5 years
Progression Free Survival (PFS)
时间窗: Up to five years
Percentage of patients who achieve partial response
时间窗: Up to 5 years
次要结局
- Grade of AE(Up to 5 years)
- Health-related quality of life (HRQoL)(Up to five years)
- Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)(Up to five years)
- Healthcare resource utilization measured by imputed costs(Up to five years)
- Drivers of Treatment Choice(Up to five years)