NCT00077961终止1 期
Phase I/II Study of Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma
Genzyme, a Sanofi Company10 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2003年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 10
研究概览
简要总结
The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response.
详细描述
This study is being conducted in 2 parts. Phase I will involve dose escalation of subcutaneous CAMPATH (SQ) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (MTD). In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining Overall Response (OR) to this combination.
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
- •For the Phase I portion of the study, patients must have pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma that has relapsed or is refractory. For the Phase II portion of the study, patients must have a pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma (Follicular, predominantly small cleaved or follicular, mixed small cleaved and large cell, International Working Formulation classification B or C or REAL classification follicular center grade 1,2) that has relapsed or is refractory.
- •Previously treated with at least one anti-cancer regimen for NHL
- •Measurable disease (lesions that can be accurately measured in 2 dimensions by CT scan with a greatest transverse diameter of >/= to 2cm or palpable lesions with both diameters of 2cm or more)
- •Life expectancy of at least 12 weeks
- •WHO performance status or 0 or 1
- •Adequate marrow and organ function (as defined in the protocol)
- •Completed major surgery, radiotherapy, chemotherapy, immunotherapy or biotherapy/targeted therapies at least 4 weeks prior to study entry (6 weeks if treated with a nitrosourea or mitomycin). Patients must have recovered from all prior treatment toxicity to Grade 1 or less, exclusive of alopecia.
排除标准
- •Prior combination therapy with rituximab and CAMPATH; prior therapy with either agent alone is permitted
- •A history of a T-cell lymphoma
- •Known AIDS-related HIV-positive lymphoma
- •For the Phase II portion of the study (once MTD has been determined), bulky disease, ie, any single mass >10cm or circulating malignant cells of 25,000/uL or more
- •Prior autologous bone marrow or stem cell transplant within 6 months of study entry
- •Prior allogeneic bone marrow transplant or organ transplant
- •Prior radiotherapy to the only site of measurable disease
- •Medical condition requiring chronic use of oral, high-dose corticosteroids
- •Use of investigational agents within 30 days of study enrollment
- •Past history of anaphylaxis following exposure to humanized monoclonal antibodies
- •Known, active, infection, including HIV positive
- •Diagnosis of another malignancy within the previous five (5) years, unless the probability of recurrence of the prior malignancy is < 5%. Patients with curatively treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN), and patients with a history of malignant tumor in the past that have been disease-free for at least 5 years
- •Active central nervous system (CNS) involvement with lymphoma
- •Pregnant or nursing women
- •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
- •Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization
研究者
研究点 (10)
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