Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) With Pentostatin, Alemtuzumab, and Low Dose Rituximab: A Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 41
- 试验地点
- 3
- 主要终点
- Complete Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as pentostatin, 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 alemtuzumab and 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. Giving pentostatin together with alemtuzumab and rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving pentostatin together with alemtuzumab and rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
详细描述
OBJECTIVES:
Primary
- To assess the rate of complete and overall response in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with pentostatin, alemtuzumab, and low-dose rituximab.
- To monitor and assess toxicity of this treatment regimen.
Secondary
- To determine the overall and progression-free survival, duration of response, and time to next treatment.
- To assess the correlation between individual prognostic markers (17p-, 11q-, unmutated VH gene, VH3-21, ZAP-70+, CD38+, CD49d, and β2 microglobulin, miRNA profiles, angiogenesis status, and karyotypes of CpG stimulated cells) and clinical outcome.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (Pentostatin, Alemtuzumab, Rituximab)
Course 1: Patients receive:
- 2 mg/m^2 pentostatin IV on days 8 and 22;
- 3 mg alemtuzumab subcutaneously (SC) on day 3;
- 10 mg alemtuzumab SC on day 4;
- 30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
- 20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
- 6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
- 2 mg/m^2 pentostatin IV on days 1 and 15;
- 30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
- 20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
- 6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3).
干预措施: alemtuzumab (Biological)
Treatment (Pentostatin, Alemtuzumab, Rituximab)
Course 1: Patients receive:
- 2 mg/m^2 pentostatin IV on days 8 and 22;
- 3 mg alemtuzumab subcutaneously (SC) on day 3;
- 10 mg alemtuzumab SC on day 4;
- 30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
- 20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
- 6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
- 2 mg/m^2 pentostatin IV on days 1 and 15;
- 30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
- 20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
- 6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3).
干预措施: rituximab (Biological)
Treatment (Pentostatin, Alemtuzumab, Rituximab)
Course 1: Patients receive:
- 2 mg/m^2 pentostatin IV on days 8 and 22;
- 3 mg alemtuzumab subcutaneously (SC) on day 3;
- 10 mg alemtuzumab SC on day 4;
- 30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
- 20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
- 6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
- 2 mg/m^2 pentostatin IV on days 1 and 15;
- 30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
- 20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
- 6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3).
干预措施: pentostatin (Drug)
Treatment (Pentostatin, Alemtuzumab, Rituximab)
Course 1: Patients receive:
- 2 mg/m^2 pentostatin IV on days 8 and 22;
- 3 mg alemtuzumab subcutaneously (SC) on day 3;
- 10 mg alemtuzumab SC on day 4;
- 30 mg alemtuzumab SC on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
- 20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
- 6 mg Sargramostim (GM-CSF) SC on days 10-14. Patients then proceed to course 2.
Courses 2 and 3: Patients receive:
- 2 mg/m^2 pentostatin IV on days 1 and 15;
- 30 mg alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
- 20 mg/m^2 rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26;
- 6 mg GM-CSF SC on days 3-7. After completion of course 2, patients with a complete response proceed to observation. Patients with a partial response or stable disease receive another course of therapy (course 3).
干预措施: sargramostim (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total)
A Complete Response (CR) requires the disappearance of all nodes, a non-palpable liver and spleen, no constitutional symptoms, absolute neutrophil counts \>1500/uL, platelets \>100000/uL, Hemoglobin \>11.0 g/dL, and lymphocytes \<4000/uL. In addition, a bone marrow biopsy with evidence of \<30% lymphocytes and no nodules. Here we report the rate of complete response as the number of patients attaining a CR status divided by the total number of evaluable patients. The 95% CI is estimated using the binomial distribution.
次要结局
- Progression-free Survival(Follow-up status and retreatment information will be collected up to 5 years from registration)
- Overall Response Rate (Complete and Partial Response)(Up to 3 cycles of treatment and 2 cycles of observation (up to 5 months total))
- Overall Survival(Follow-up status and retreatment information will be collected up to 5 years from registration)
- Time to Retreatment(Follow-up status and retreatment information will be collected up to 5 years from registration)