Phase III, Double-Blind, Randomized, Placebo-Controlled Trial of FavID® (Id/KLH) and GM-CSF Following CHOP/Rituximab as First-Line Therapy in Subjects With High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 480
- 试验地点
- 4
- 主要终点
- Disease-free survival as measured by the Kaplan-Meier method at 3 years
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. It is not yet known whether giving GM-CSF together with vaccine therapy is more effective than giving GM-CSF together with a placebo when given after combination chemotherapy and rituximab in treating diffuse large B-cell lymphoma.
PURPOSE: This randomized phase III trial is studying GM-CSF and vaccine therapy to see how well they work compared to GM-CSF and placebo when given after combination chemotherapy and rituximab as first-line therapy in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- Compare the 3-year disease-free survival of patients with high-intermediate- or high-risk bulky stage II or stage III or IV diffuse large B-cell lymphoma treated with sargramostim (GM-CSF) with or without autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId®) after combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP-R).
Secondary
- Compare the 2-year disease-free survival, duration of response, time to progression, overall survival, and safety in patients treated with these regimens.
- Estimate the rate of immune reactivity to FavId®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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 lymphoma
- •Bulky stage II or stage III or IV disease
- •Treatment naïve
- •International Prognostic Index score of 3 (high-intermediate) or 4/5 (high)
- •Lymphoma accessible for sampling or existing biopsy material judged suitable for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId®)
- •No history of CNS lymphoma or meningeal lymphomatosis
- •No history of indolent lymphoma
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Platelet count > 75,000/mm^3
- •ALT and AST < 2 times upper limit of normal
- •Not pregnant or nursing
- •No history of unresolved hepatitis B viral infection
- •No history of a treated prior malignancy unless in remission ≥ 2 years, except for treated nonmelanoma carcinomas of the skin or in situ cervical carcinomas or prostatic carcinomas
- •No contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on ECG)
- •No contraindication to vincristine (e.g., peripheral neuropathy)
- •No know HIV positivity
- •No serious nonmalignant disease, including any of the following:
- •Psychiatric disorders
- •Compromised pulmonary function
- •Congestive heart failure
- •Active bacterial, viral, or fungal infections
- •PRIOR CONCURRENT THERAPY:
- •No prior keyhole limpet hemocyanin
- •No planned radiotherapy during or after study therapy
- •No concurrent systemic immunosuppressive therapy (e.g., steroids)
排除标准
- 未提供
结局指标
主要结局
Disease-free survival as measured by the Kaplan-Meier method at 3 years
次要结局
- Disease-free survival as measured by the Kaplan-Meier method at 2 years
- Duration of response (complete or partial response)
- Overall disease-free survival