A Phase II Trial of Rituximab + Oblimersen Sodium (GenasenseTM, G3139, NSC #683428, IND #58842) in Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Overall response (OR) rate defined as achievement of a complete (CR) or partial response (PR) as the best observed response
研究概览
简要总结
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. Oblimersen may help rituximab work better by making cancer cells more sensitive to the drug. This phase II trial is studying how well giving rituximab together with oblimersen works in treating patients with stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma
详细描述
PRIMARY OBJECTIVES:
I. To determine the response rate (overall and complete response rate) after rituximab + oblimersen sodium extended induction therapy in previously untreated cluster of differentiation 20 positive (CD20+) follicular non-Hodgkin lymphoma (NHL) patients.
II. To determine the time to progression after rituximab + oblimersen sodium extended induction therapy in previously untreated CD20+ follicular NHL patients.
SECONDARY OBJECTIVES:
I. To determine the toxicity profile of rituximab + oblimersen sodium therapy in previously untreated CD20+ follicular NHL patients.
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
- •Previously untreated, histologically confirmed follicular lymphoma, WHO classification, grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) which is stage III, IV, or bulky (i.e., single mass >= 7 cm in any unidimensional measurement) stage II
- •Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression
- •Patients classified as high risk according to the Follicular Lymphoma International Prognostic Index (FLIPI) should be considered for CALGB 50102/SWOG S0016
- •No prior therapy for non-Hodgkin lymphoma including chemotherapy, radiation or immunotherapy (e.g., monoclonal antibody-based therapy)
- •No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease
- •ECOG performance status 0-2
- •Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm is acceptable; lesions that are considered non-measurable include the following:
- •Bone lesions (lesions if present should be noted)
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Bone marrow (involvement by non-Hodgkin lymphoma should be noted)
- •No known CNS involvement by lymphoma
- •No known HIV infection
- •Non-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth control throughout their participation in this study; appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
- •Patients with a "currently active" second malignancy, other than nonmelanoma skin cancers are not eligible; (this includes Waldenstrom's Macroglobulinemia, since such patents have experienced transient increases in IgM following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis); patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse
- •ANC >= 1000/uL
- •Platelet count >= 50,000/uL
- •Creatinine =< 2 x ULN
- •Total bilirubin =< 2 x ULN; unless attributable to Gilbert's disease
排除标准
- 未提供
结局指标
主要结局
Overall response (OR) rate defined as achievement of a complete (CR) or partial response (PR) as the best observed response
时间窗: 12 months
The true OR rate will be estimated using the uniformly minimum unbiased estimator. Jennison and Turnbull's method will be used to obtain 95% exact confidence interval for the true OR rate of each arm reflecting the above two-stage design.
次要结局
- Toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0(Up to 10 years)
- Time-to-progression (TTP)(Up to 10 years)
- Time-to-best response(Up to 10 years)
- Overall survival(Up to 10 years)