Rituximab In Combination With Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also be studied.
详细描述
GM-CSF is a drug designed to stimulate the immune system. It will increase the number of a certain type of blood cell called neutrophils and macrophages.
Rituximab is a drug designed to bind to a protein, called cluster of differentiation antigen 20 (CD20), that is on the surface of the leukemia cells, allowing the leukemia cells to be destroyed by the immune system.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including routine blood tests (about 2 tablespoons). A bone marrow aspirate will be collected. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Imaging studies (such as a chest x-ray or CT scans) may be performed. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will receive GM-CSF as an injection under the skin, three times a week for eight weeks. You will receive rituximab by vein, once a week for four weeks. Usually, the first dose of rituximab requires several hours to complete. Later doses should usually be shorter, but may vary according to individual tolerance. Acetaminophen (Tylenol), diphenhydramine hydrochloride (Benadryl), and steroids (hydrocortisone or similar) will be given before rituximab to decrease the risk of side effects. If side effects do occur during the infusion, you will need to stay at the hospital and be observed until the side effects have gone away. Other than that, treatment will be given on an outpatient basis.
During treatment you will have routine blood tests (about 1 tablespoon) once a week. The treatment will take about 8 weeks to be completed. You will be taken off study if your disease gets worse or if the side effects become too severe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of previously treated B-CLL Rai III-IV or earlier stage disease with evidence of "active disease" as defined by the NCI-sponsored working group 1) weight loss of >10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia or paraproteinemia, 7) lymphadenopathy >5 cm in diameter.
- •Diagnosis of previously untreated B-CLL with Rai stage 0-II disease but high risk for progression based on B2-microglobulin >3.0 mg/mL, or with symptoms or significant fatigue.
- •Patients age 70 years of age and older with previously untreated B-CLL and Rai stage III-IV or earlier stage disease with indication for treatment who refused chemotherapy.
- •Age 15 years or above.
- •Adequate renal and hepatic functions (creatinine <2.5 mg/dL, bilirubin <2 mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes are eligible, as are patients with elevated bilirubin and history consistent with Gilbert's disease.
- •Performance status <3 (Zubrod Scale).
- •No active viral hepatitis
排除标准
- 未提供
研究组 & 干预措施
Treated and Relapsed - Group 1
Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
干预措施: GM-CSF (Sargramostim) (Drug)
Treated and Relapsed - Group 1
Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
干预措施: Rituximab (Drug)
Treated and High-Risk for Progression - Group 2
Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
干预措施: GM-CSF (Sargramostim) (Drug)
Treated and High-Risk for Progression - Group 2
Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
干预措施: Rituximab (Drug)
70 Years of Age and Refused Chemo - Group 3
Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
干预措施: GM-CSF (Sargramostim) (Drug)
70 Years of Age and Refused Chemo - Group 3
Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Blood tests once a week during 8 weeks of treatment.
Overall Response Rate - Complete Response (CR) + Partial Response (PR). CR is the absence of Lymphocyte infiltrates on biopsy, \<30% Lymphocytes on Bone Marrow Aspirate, Lymphocytes \< 4,000ul , Hemoglobin \>11.0 g/dl , Platelets \>1000,000/ul, Polymorphonuclear neutrophils (PMN) \>1,500/ul, Liver/Spleen not palpable, Nodes none. PR is \<30% Lymphocytes with residual disease on biopsy for nodular PR, Lymphocytes \>50% decrease, Hemoglobin (un-transfused) \> 11.0 g/dl or \>50% improvement from baseline, Platelets \> 100,000/ul or 50% improvement from baseline, PMN \>1,500 ul or 50% improvement from baseline, Liver/Spleen \>/= 50% decrease, Nodes \>/= 50%.
次要结局
未报告次要终点