Rituximab (IDEC-C2B8) Plus GM-CSF in Patients With Follicular B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Overall Response Rate of Rituximab plus GM-CSF of repeat doses (once weekly times four)
研究概览
简要总结
The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment will also be studied.
详细描述
Rituximab seeks out and helps destroy cancer cells. GM-CSF stimulates the body to produce white blood cells.
Before treatment starts, patients will have a complete exam, including blood and urine tests. A chest x-ray and a CT scan or MRI scan of the abdomen and pelvis will be done to measure tumors. Bone marrow and lymph node samples will be taken.
Women who are able to have children must have a negative blood pregnancy test.
Patients in this study will receive both rituximab and GM-CSF. The combined treatment will last 8 weeks.
Rituximab will be given through a needle in a vein over 3-6 hours once a week. GM-CSF will be given through a needle under the skin 3 times a week. The first of these 3 doses will be usually given 1 hour before the rituximab dose. In selected cases, GM-CSF will start 1 week before or 1 day after the rituximab.
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
- •Histologically confirmed follicular B-cell lymphoma. This can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. Previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.
- •Males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or
- •Demonstrable monoclonal cluster of differentiation antigen 20 (CD20)-positive B-cell population.
- •Acceptable hematologic status including:
- •i. hemoglobin (Hgb) =/> 8.0 gm/dL
- •ii. White blood count (WBC) =/> 3.0 x 10^3/mm^3(x 10^9/L)
- •iii. Absolute granulocyte count =/> 1.5 x 10^3/mm^3
- •iv. Platelet count =/>75 x 10^3/mm^3
- •e. Adequate renal function (serum creatinine ≤ 2mg/dl)
排除标准
- •presence of Central Nervous System (CNS) Lymphoma
- •chronic lymphocytic leukemia (CLL)
- •small lymphocytic lymphoma
- •therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for Bone Marrow Transplantation (BMT))
- •patients who received prior rituximab or other anti-CD20 therapy
- •serious non-malignant disease, or other malignancy
- •active infection
- •history of HIV infection
- •i pregnancy
研究组 & 干预措施
Rituximab + GM-CSF
All patients receive one (1) course of therapy consisting of four (4) doses of rituximab, a single dose 375 mg/m^2 administered once weekly for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly (tiw) for 8 weeks, starting 1 hour before the first dose of rituximab. In selected cases, the GM-CSF starts 1 week before, or 1 day after, the first rituximab dose.
干预措施: Rituximab (Drug)
Rituximab + GM-CSF
All patients receive one (1) course of therapy consisting of four (4) doses of rituximab, a single dose 375 mg/m^2 administered once weekly for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly (tiw) for 8 weeks, starting 1 hour before the first dose of rituximab. In selected cases, the GM-CSF starts 1 week before, or 1 day after, the first rituximab dose.
干预措施: GM-CSF (Drug)
结局指标
主要结局
Overall Response Rate of Rituximab plus GM-CSF of repeat doses (once weekly times four)
时间窗: 1 month
Response Rate is the number of participants with response compared to total. Response definitions: Complete response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. Complete response "unconfirmed" (CRu) defined on the basis of minimal residual abnormalities on x-ray such as a residual mass \<25% of original measurement with no palpable disease on physical examination. Partial response (PR) defined as 50-75% reduction in the product of palpable tumor diameters of in the tumor volume measurements by radiologic criteria or any palpable disease such as peripheral node(s) \> 1 cm in diameter or palpable abdominal mass with histological evidence of lymphoma cells. Minor response or failure includes \<50% tumor shrinkage, or \> 50% but with tumor regrowth between courses.
次要结局
未报告次要终点