A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 240
- 主要终点
- Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- To assess the 5-year progression-free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission tomography (PET)/CT scan to direct therapy after 3 courses of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP).
Secondary
- To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients with newly diagnosed limited-stage DLBCL.
- To evaluate toxicity of the protocol treatments in this patient population.
- To evaluate the response probability in this patient population.
- To evaluate overall survival in the overall population, and within the PET+ and PET- subgroups.
- To estimate the rate of upstaging at baseline by PET/CT at baseline among patients newly diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in patients upstaged by PET/CT at baseline to advanced DLBCL.
- To describe outcomes in the subgroup of patients upstaged by PET/CT.
- To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs stromal-2 gene expression signatures with PFS or overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PET Positive: IFRT +Zevalin
Standard IFRT+ Zevalin IV per ABW
干预措施: yttrium Y 90 ibritumomab tiuxetan (Radiation)
PET Negative: R-CHOP
R-CHOP x 3 Cycles
干预措施: rituximab (Biological)
PET Negative: R-CHOP
R-CHOP x 3 Cycles
干预措施: cyclophosphamide (Drug)
PET Negative: R-CHOP
R-CHOP x 3 Cycles
干预措施: doxorubicin hydrochloride (Drug)
PET Negative: R-CHOP
R-CHOP x 3 Cycles
干预措施: prednisone (Drug)
PET Negative: R-CHOP
R-CHOP x 3 Cycles
干预措施: vincristine sulfate (Drug)
PET Negative: R-CHOP
R-CHOP x 3 Cycles
干预措施: R-CHOP regimen (Other)
PET Negative: R-CHOP
R-CHOP x 3 Cycles
干预措施: laboratory biomarker analysis (Other)
PET Positive: IFRT +Zevalin
Standard IFRT+ Zevalin IV per ABW
干预措施: rituximab (Biological)
PET Positive: IFRT +Zevalin
Standard IFRT+ Zevalin IV per ABW
干预措施: laboratory biomarker analysis (Other)
PET Positive: IFRT +Zevalin
Standard IFRT+ Zevalin IV per ABW
干预措施: fludeoxyglucose F 18 (Radiation)
PET Positive: IFRT +Zevalin
Standard IFRT+ Zevalin IV per ABW
干预措施: selective external radiation therapy (Radiation)
结局指标
主要结局
Five-year Progression-free Survival (PFS) Rate in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma (DLBCL)
时间窗: up to 5 years
Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive without report of progression or relapse are censored at date of last contact. Progressions is defined using the 2007 revised Cheson et. Al. criteria, as ≥50% increase in the sum of the products of diameters (SPD) of target measurable lesions, appearance of any new bone marrow involvement, or appearance of any new lesion \>1.5 cm in the longest axis.
次要结局
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug(up to 4 months or time of disease progression.)
- Progression-free Survival (PFS) Within the PET+ and PET- Subgroups of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)(up to 5 years)
- Overall Survival of Patients With Newly Diagnosed Limited-stage Diffuse Large B-Cell Lymphoma (DLBCL)(up to 5 years)
- Response Rates in Patients With Newly Diagnosed Limited Stage Diffuse Large B-cell Lymphoma Using PET/CT Scan to Direct Therapy After 3 Cycles of R-CHOP(Up to 4 months)
- Association of Germinal Center B-cell Subtype (GCB) vs Stromal-1 vs Stromal-2 Gene Expression Signatures With PFS or Overall Survival.(5 years)