NCT00022685Unknown3 期
A Phase III Clinical Trial of Immunotherapy With Humanized LL2 IgG (Epratuzumab) in Patients With Low-Grade Follicular, B-Cell Non-Hodgkin's Lymphoma Refractory to Rituxan (Rituximab)
适应症
试验速览
- 阶段
- 3 期
- 试验地点
- 1
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: Phase III trial to determine the effectiveness of epratuzumab in treating patients who have low-grade non-Hodgkin's lymphoma that has not responded to chemotherapy or rituximab.
详细描述
OBJECTIVES:
- Determine the safety of epratuzumab in patients with rituximab-refractory low-grade follicular B-cell non-Hodgkin's lymphoma.
- Confirm the convenient administration of this drug in this patient population.
- Determine the efficacy of this drug in terms of objective response rate in these patients.
- Determine the duration of response and time to progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive epratuzumab IV over 15-60 minutes on days 1, 8, 15, and 22.
Patients are followed every 8 weeks for 10 months and then every 3 months for up to 4 years.
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 low-grade follicular B-cell non-Hodgkin's lymphoma
- •Small cleaved cell OR
- •Mixed cell
- •The following are ineligible:
- •Primary CNS lymphoma
- •HIV lymphoma
- •Richter's lymphoma
- •Bulky disease (any single mass greater than 10 cm)
- •Pleural effusion with positive cytology for lymphoma
- •Failed prior standard chemotherapy for non-Hodgkin's lymphoma
- •Refractory to at least 1 prior treatment with rituximab
- •Disease progression or failure to achieve objective response within 6 months of beginning rituximab therapy
- •At least 1 bidimensionally measurable lesion
- •At least 1.5 cm by CT scan NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 4 months
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 50,000/mm^3
- •Hemoglobin at least 8 g/dL
- •Transfusion independent
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
- •Alkaline phosphatase less than 2 times ULN*
- •AST less than 2 times ULN* NOTE: *Unless lymphoma-related
- •Creatinine no greater than 1.5 times ULN unless lymphoma-related
- •No other malignancy within the past 5 years except squamous or basal cell skin cancer or carcinoma in situ of the cervix
- •No other serious condition or infection that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •At least 12 weeks since prior autologous stem cell transplantation
- •No prior radioimmunoconjugate therapies
- •Chemotherapy:
- •See Disease Characteristics
- •No more than 4 prior treatment regimens
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •At least 2 weeks since prior corticosteroids
- •No concurrent steroids
- •Radiotherapy:
- •See Biologic therapy
- •At least 4 weeks since prior radiotherapy to target lesion
- 另有 3 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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