Randomized Phase II Study Of Interleukin-12 In Combination With Rituximab In Patients With Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Objective response
研究概览
简要总结
Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more cancer cells. This randomized phase II trial is comparing how well giving rituximab together with two different schedules of interleukin-12 works in treating patients with B-cell non-Hodgkin lymphoma.
详细描述
OBJECTIVES:
I. Compare the objective response in patients with B-cell non-Hodgkin's lymphoma treated with rituximab and 2 different schedules of interleukin-12*.
II. Compare the toxic effects of these regimens in these patients. III. Determine the objective response rate in patients with mantle cell lymphoma treated with these regimens.
IV. Determine the overall and progression-free survival of patients treated with these regimens.
V, Compare the quality of life of patients treated with these regimens. NOTE: *Interleukin-12 will no longer be available after 6/30/05.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma
- •Previously treated low-grade lymphoma considered incurable with standard therapy
- •Grade I or II follicular lymphoma*
- •Lymphoplasmacytic lymphoma*
- •Small lymphocytic lymphoma*
- •Nodal marginal zone lymphoma*
- •Extranodal marginal zone lymphoma of MALT type*
- •Splenic marginal zone lymphoma*
- •Previously treated mantle cell lymphoma allowed
- •Meets one of the following criteria for measurable disease:
- •Bidimensional diameter at least 1.5 cm by 1.5 cm on physical exam
- •At least 2 cm in one dimension by CT scan, MRI, or plain radiograph imaging
- •Palpable spleen at least 5 cm below the left costal margin
- •No CNS involvement by lymphoma
- •Performance status - ECOG 0-1
- •At least 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Hemoglobin ≥ 8 g/dL
- •Bilirubin ≤ 3 times upper limit of normal (ULN)
- •AST and ALT ≤ 3 times ULN
- •Alkaline phosphatase ≤ 3 times ULN
- •Creatinine ≤ 2 times ULN
- •No New York Heart Association class III or IV heart disease
- •No history of angina
- •No uncontrolled peptic ulcer disease
- •No uncontrolled infection
- •No other active malignancy
- •No autoimmune-related phenomena (e.g., antinuclear antibody less than 2 times ULN, rheumatoid factor less than 2 times ULN, and negative direct Coombs)
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Prior stem cell transplantation allowed
- •More than 12 months since prior rituximab
- •No prior interleukin-12
- •No other concurrent immunotherapy
- •Recovered from prior chemotherapy
- •No concurrent chemotherapy
- •No concurrent steroid therapy
- •No concurrent radiotherapy
- •Any number of prior therapies allowed
排除标准
- 未提供
结局指标
主要结局
Objective response
时间窗: 24 weeks
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. In addition, confidence intervals for the response probability will be calculated according to the approach of Duffy and Santner.
次要结局
- Overall response rate for MCL patients(Up to 5 years)
- Overall survival(From randomization to death due to any cause, assessed up to 5 years)
- Time to treatment failure(From randomization to the treatment-specific definition of disease progression, death, or when the patient goes off study due to refusal or toxicity, assessed up to 5 years)
- Complete response rate(Up to 5 years)
- Quality of life assessed using FACT-BRM(6 months)