NCT00042913Unknown2 期
A Phase 2 Open Label, Randomized, Dose And Schedule Finding, Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
适应症
试验速览
- 阶段
- 2 期
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the response rate of patients with diffuse large B-cell non-Hodgkin's lymphoma treated with epratuzumab.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 4 weeks.
- Arm II: Patients receive low-dose epratuzumab IV over 1 hour once weekly for 8 weeks.
- Arm III: Patients receive high-dose epratuzumab IV over 1 hour once weekly for 4 weeks.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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 diffuse large B-cell non-Hodgkin's lymphoma (NHL)
- •Relapsed or refractory after at least 1 regimen of standard therapy
- •Prior therapy may include high-dose chemotherapy with autologous stem cell transplantation (ASCT) or immunotherapy
- •Bidimensionally measurable disease
- •At least 1 lesion at least 1.5 cm by CT scan
- •No primary or secondary CNS lymphoma
- •No HIV-related lymphoma
- •No known or suspected transformed lymphoma (prior or concurrent)
- •No bulky disease (i.e., any single mass greater than 10.0 cm)
- •No pleural effusion with positive cytology for lymphoma
- •Most recent pathology specimen available for collection
- •No rapid disease progression or symptoms that indicate disease progression requiring rapid intervention within the past 2 weeks (e.g., severe shortness of breath, severe pain, or gastrointestinal or genitourinary obstruction)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 4 months
- •Hematopoietic
- •Absolute neutrophil count at least 1,000/mm3
- •Platelet count at least 50,000/mm3 (transfusion independent)
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST and ALT less than 5 times ULN
- •Hepatitis B surface antigen negative
- •Hepatitis C negative
- •Creatinine no greater than 2 times ULN
- •HIV negative
- •No other primary malignancy within the past 3 years except squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer
- •No other serious nonmalignant condition that would preclude study
- •No serious infection
- •No known human antichimeric antibodies or human antihuman antibody positivity
- •No type 1 hypersensitivity or anaphylactic reactions to murine proteins
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •At least 4 weeks since prior immunotherapy (unless clearly progressing)
- •At least 12 weeks since prior ASCT
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (unless clearly progressing)
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radioimmunotherapy
- •At least 4 weeks since prior major surgery (unless patient has fully recovered)
- •At least 30 days since prior enrollment in clinical trials involving investigational devices or drugs
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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