NCT00363090Unknown1 期
Alemtuzumab and CHOP Chemotherapy for Aggressive Histology Peripheral T Cell Lymphomas: A Multi-Centre Phase I and II Study
Toronto Sunnybrook Regional Cancer Centre10 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 84
- 试验地点
- 10
- 主要终点
- Dose-limiting toxicities
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, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, 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/II trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed aggressive stage II, stage III, or stage IV T-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Establish the safety and dose-limiting toxicities of alemtuzumab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) chemotherapy in patients with newly diagnosed, stage II-IV aggressive peripheral T-cell non-Hodgkin's lymphoma.
- Measure the pharmacokinetics of alemtuzumab using different subcutaneous doses and schedules to determine the dose with the highest achievable drug levels with acceptable toxicities worthy of further investigation.
Secondary
- Determine the efficacy of alemtuzumab in combination with CHOP chemotherapy using escalating doses and 2 different drug schedules, as defined by overall response rate, progression-free survival, and overall survival.
- Measure the effects of this regimen on T-cell reconstitution and cytomegalovirus reactivation.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed aggressive peripheral T-cell non-Hodgkin's lymphoma (NHL), including the following nodal or extranodal subtypes:
- •Angioimmunoblastic lymphadenopathy
- •ALK 1-negative anaplastic large cell NHL
- •Peripheral T-cell lymphoma not otherwise specified
- •Extranodal:
- •Hepatosplenic NHL
- •Enteropathy-associated NHL
- •Panniculitic NHL
- •Stage II-IV disease
- •Newly diagnosed, CD52+ disease
- •Measurable or evaluable disease
- •No known CNS involvement with lymphoma
- •No nasal natural killer T-cell NHL
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 4 months
- •Absolute neutrophil count ≥ 1,000/mm³*
- •Platelet count ≥ 75,000/mm³*
- •Hemoglobin ≥ 8.5 g/dL*
- •Bilirubin < 2.0 mg/dL
- •Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
- •AST or ALT < 2 times ULN
- •Creatinine < 1.5 mg/dL*
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known hypersensitivity to any of the study drugs
- •No serious illnesses that would preclude compliance with study requirements
- •No known HIV positivity
- •No other preexisting immunodeficiency (e.g., post-organ transplant)
- •No other malignancy within the past 5 years except cervical carcinoma in situ or nonmelanoma skin cancer NOTE: *Unless directly attributable to NHL
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy
- •Up to 7 days of prednisone preceding initiation of chemotherapy allowed
- •No other concurrent chemotherapy, radiotherapy, or immunotherapy
- •No other concurrent corticosteroids except dexamethasone used as an antiemetic for a brief period
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicities
Pharmacokinetics of alemtuzumab
Toxicity as assessed by NCI Common Toxicity Criteria Version 3.0
Safety
次要结局
- Efficacy as assessed by clinical, radiologic, pathologic, and laboratory measurements
- Overall response rate
- Progression-free survival
- Overall survival
- Effects of treatment on T- and B-cell reconstitution by flow cytometry at baseline and at 3, 6, and 12 months
研究者
研究点 (10)
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