CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Immediate toxicity (incidence of infusion-related reactions)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as alemtuzumab, 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. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine the feasibility of adding alemtuzumab to standard cyclophosphamide, doxorubicin hydrochloride, vincristine, and oral prednisolone (CHOP) chemotherapy in patients with stage I-IV peripheral T-cell lymphoma (PTCL).
- To assess the side effect profile and early and late toxicities of this regimen in a standard dose-escalation design, and to establish an appropriate dose level for future studies.
Secondary
- To document response rates and disease-free survival of patients treated with this regimen, and to compare these findings with those of historical controls.
- To monitor immune reconstitution after therapy.
- To determine the pharmacokinetics of subcutaneous alemtuzumab when given in combination with CHOP chemotherapy.
- To more clearly define the CD52 expression profile in these tumors and to investigate phenotypic variations in PTCL.
- To document changes (if any) in levels of Epstein-Barr virus copy number by polymerase chain reaction during CHOP-alemtuzumab therapy.
研究设计
- 研究类型
- Interventional
- 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
结局指标
主要结局
Immediate toxicity (incidence of infusion-related reactions)
Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)
次要结局
- Disease response (remission rate [complete response and partial response])
- Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
- Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
- Relative dose intensity
- Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
- Epstein-Barr virus copy number (measured retrospectively)