Immuno-Augmentation With GM-CSF in Patients Receiving Pneumococcal Vaccine While Undergoing Treatment for Advanced Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine
研究概览
简要总结
The goal of this clinical research study is to see if Leukine(R) (sargramostim) improves the effectiveness of the pneumococcal vaccine, a medicine used to prevent pneumococcal pneumonia, in patients with chronic lymphocytic leukemia (CLL).
详细描述
Sargramostim (also commonly called granulocyte macrophage colony stimulating factor - GM-CSF) is a medication used to stimulate the bone marrow production of white blood cells before a stem cell transplant, after chemotherapy or after a bone marrow transplant. Pneumococcal vaccine is a medication used to prevent infections caused by a bacteria called Streptococcus pneumoniae.
If you have not had a gammaglobulins test (a test to measure immunity against certain infectious diseases) measured within three months before the study begins, then this blood test will be done before you receive any study medications.
Women who are able to have children must have a negative urine pregnancy test before starting treatment.
After consenting to this study, you will be randomly assigned (as in the toss of a coin) to receive treatment with sargramostim in addition to the pneumococcal vaccine or to receive pneumococcal vaccine alone (Prevnar).
- If you are randomized to vaccine plus sargramostim group, you will receive an injection of sargramostim at the same time you receive the pneumococcal vaccine.
- If you are randomized to the vaccine alone group, you will receive the pneumococcal vaccine on the first day.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in complete / partial remission or those with active Chronic lymphocytic leukemia (CLL) with Rai stage 0 to 4.
排除标准
- •Patients will not be entered while neutropenic (PMNs < 500 cells/mm3) or having received Rituximab within 6 months.
- •Patients will not be entered while febrile (Temperature > 38 degrees C) within 1 week.
- •Active infection.
- •Patients with known Human immunodeficiency virus (HIV) infection.
- •Known history of allergy to Granulocyte/ macrophage colony stimulating factor (GM-CSF) or pneumococcal vaccine.
- •Chemotherapy other than Campath, fludarabine, cyclophosphamide, in 4 weeks.
- •Patients who have previously received pneumococcal vaccine within the preceding 12 months.
- •Absolute lymphocyte count less than 500 cells/mm3.
研究组 & 干预措施
Pneumococcal Vaccine + GM-CSF
Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
干预措施: Sargramostim (GM-CSF) (Drug)
Pneumococcal Vaccine Alone
First vaccine dose subcutaneously, Day 0.
干预措施: Pneumococcal Vaccine (Biological)
结局指标
主要结局
Number of Participants (With Increase) Immune Response to GM-CSF With a Pneumococcal Vaccine
时间窗: Baseline and at 1 month after vaccine.
Response defined as 2-fold rise in anticapsular immunoglobulin G (IgG) when prevaccination titer is compared with levels post vaccination and with a final level of \>0.5 ug/mL. Anti-pneumococcal immunoglobulin titers measured at baseline and 1 month after vaccine. Response determined by measuring serum IgG to capsular polysaccharides from 6 of the most common infecting serotypes of Streptococcus pneumoniae.
次要结局
未报告次要终点