Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.
研究概览
简要总结
RATIONALE: Analyzing genes that are present in cancer cells may be useful as a method for predicting the response of non-Hodgkin's lymphoma to cancer treatment. Imaging procedures such as positron emission tomography (PET) scans may improve the ability to measure how well cancer has responded to treatment.
PURPOSE: This phase II trial is studying molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine whether molecular risk assessment can identify groups of patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL) who will demonstrate at least 50% difference in early response rates to treatment as determined by positron-emission tomography (PET) imaging.
- Determine, by PET imaging, the response rate of patients treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab.
- Determine whether early response rates can be predicted by gene expression profiles at diagnosis in these patients.
- Compare gene expression profiles of patients with refractory or relapsed large cell NHL with profiles of the disease at diagnosis.
- Determine relapse-free and overall survival rates of these patients.
- Determine the feasibility of a new NHL treatment algorithm based on prognostic index and molecular risk, and early response assessment by PET imaging.
OUTLINE: Molecular risk assessment is performed using lymph node tissue from initial diagnosis to test for "activated" genes before starting treatment.
Patients receive rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses. Patients undergo whole-body positron-emission tomography (PET) scanning at baseline and after course 3 to determine response. Results from the genetic testing and PET scans are used to determine further treatment recommendations.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma
- •CD20 and/or CD19 positive by immunohistochemistry or flow cytometry
- •Disease evaluable by positron-emission tomography scan
- •Diagnostic tissue (either frozen or fresh unfixed) available for molecular testing or willing to undergo a repeat procedure to obtain such tissue
- •No CNS involvement by lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 3 mg/dL
- •Creatinine no greater than 3 mg/dL
- •Cardiovascular
- •LVEF at least 40%
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No significant organ dysfunction that would preclude study chemotherapy
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior immunotherapy
- •No prior biological response modifier therapy
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy
- •No prior radioimmunotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.
时间窗: Results from the genetic testing and PET scans at baseline and after course 3 to determine response.
次要结局
未报告次要终点