Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 17
研究概览
简要总结
The purpose of this study is to determine the optimal dose of Campath for patients with relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also evaluate the safety of the drug and whether it is effective in treating these patients.
详细描述
This study is being conducted in 2 parts with the primary objective of part 1 being to determine the maximum tolerated dose (MTD) of CAMPATH (alemtuzumab, MABCAMPATH, CAMPATH) administered intravenously (IV) once a week as treatment for relapsing or refractory non-Hodgkin's lymphoma (NHL). The primary objective of part 2 is to determine the overall response rate (complete response, CR/unconfirmed , plus partial response) of weekly IV CAMPATH in the treatment of relapsing or refractory NHL. This is a Phase I/II study, open-label, multicenter study to evaluate the efficacy and safety of weekly IV CAMPATH as therapy for patients with relapsing or refractory non-Hodgkin's lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must have:
- •Pathologically confirmed diagnosis of relapsing or refractory non-Hodgkin's lymphoma that has failed conventional therapy.
- •Measurable disease (lesions that can be accurately measured by CT scan and a greatest transverse diameter larger or equal to 1 cm or palpable lesions that both diameters larger or equal to 2 cm).
- •Life expectancy of at least 12 weeks. - World Health Organization (WHO) performance status (PS) of 0, 1, or
- •Adequate marrow and organ function (details are listed in the protocol).
- •Female patients with childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Male and female patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months following study therapy.
- •Signed, written informed consent.
排除标准
- •Patients must not have:
- •Prior autologous bone marrow or stem cell transplant within 6 months of study entry.
- •A history of prior allogeneic bone marrow transplant or organ transplant.
- •Previously untreated non-Hodgkin's lymphoma.
- •Previously treated with CAMPATH.
- •Patients with bulky disease, ie any single mass > 7.5cm.
- •Prior radiotherapy to the only site of measurable disease.
- •Medical condition requiring chronic use of oral, high-dose corticosteroids.
- •Autoimmune thrombocytopenia.
- •Use of investigational agents within previous 30 days or any anti-cancer therapy within the previous 3 weeks. Patients must have recovered from all acute toxicities of any prior therapy.
- •Past history of anaphylaxis following exposure to humanized monoclonal antibodies.
- •Active, uncontrolled infection, including human immunodeficiency virus (HIV) positive.
- •Active secondary malignancy.
- •Active central nervous system (CNS) involvement with NHL.
- •Pregnant or lactating women. Male or female patients who do not agree to use effective contraceptive method(s) during the study.
- •Any significant concurrent disease or illness that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results.