NCT00089076终止1 期
Phase I/II Study of Anti-CTLA-4 Monoclonal Antibody (MDX-010) in B-cell Non-Hodgkin's Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of Overall Confirmed Responses(Complete Response or Partial Response)
研究概览
简要总结
Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop cancer cells from growing. This phase I/II trial is studying the side effects and best dose of MDX-010 and to see how well it works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
详细描述
PRIMARY OBJECTIVES:
I. To characterize the safety profile of MDX-010 (ipilimumab) monoclonal antibody and identify a tolerable immunologically active dose level in B cell lymphoma patients.
II. To evaluate the clinical response rate in B cell lymphoma patients treated with MDX-010.
SECONDARY OBJECTIVES:
I. To evaluate the phenotype and function of memory T cells before and after treatment with MDX-010 by:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologic proof of recurring or residual follicular B-cell non-Hodgkin's lymphoma (grade I or II), by Revised European American Lymphoma Classification (REAL) or World Health Organization (WHO) classifications which has relapsed or persisted after 3 or fewer conventional therapies, including chemotherapy or monoclonal antibody therapy; note: all patients with previously treated B-cell lymphomas of any histology with the exception of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) are eligible
- •Tumor measurable by computed tomography (CT) scans (at least one pathologic node measuring 2.0 x 2.0 cm, or 2 nodes measuring > 1.5 x 1.5 cm after collection of tumor for immunologic analyses)
- •At least one prior treatment regimen but no more than 3 prior chemotherapy regimens; patients previously treated with monoclonal antibodies or radiotherapy to a single site will be eligible; these therapies will be considered prior treatment regimens but will not be considered as prior chemotherapy; tumor vaccines will not be counted as prior therapies, as all such agents are investigational
- •Absolute neutrophil count (ANC) >= 1000/uL
- •Platelets (PLT) >= 75,000/uL
- •Total bilirubin =< 1.5 x upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) =< 3 x upper limit or normal (ULN)
- •Creatinine =< 1.5 x ULN
- •Hemoglobin >= 8 g/dL
- •Ability to provide informed consent
- •Willingness to return to the Mayo Clinic Rochester or the University of California, Los Angeles for follow up
- •Life expectancy >= 24 weeks
- •Willingness to provide all biologic specimens as required by the protocol
排除标准
- •Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, 3, or 4
- •Any uncontrolled infection, hepatitis C virus (HCV)+ (unless HCV ribonucleic acid [RNA]-negative by polymerase chain reaction [PCR]) or hepatitis B surface antigen (HBsAg)+, or human immunodeficiency virus (HIV) positive patients or patients with known immune deficiency states
- •Previous MDX-010 therapy regardless of interval since last treatment
- •Prior treatment with fludarabine or 2-chlorodeoxyadenosine =< 12 months prior to registration
- •Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
- •New York Heart Association classification III or IV or a history of angina pectoris requiring active treatment
- •Clinical evidence of central nervous system involvement by lymphoma
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
- •Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
- •Diagnosis of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL)
- •Any requirement for concurrent steroid therapy, including use of inhaled steroids for asthma
- •History of autoimmune disease requiring systemic therapy with immunosuppressive drugs, including but not limited to rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, or psoriasis
- •Antinuclear antibody (ANA) titer or rheumatoid factor titer > 3x institutional ULN
结局指标
主要结局
Number of Overall Confirmed Responses(Complete Response or Partial Response)
时间窗: From registration to month 7
Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
次要结局
- Overall Survival (Phase 2)(From registration to death (up to 2 years))
- Mean Change in % of CD3+CD4- for Marker HLA-DR+(Before treatment to 1 month after therapy initiation)
- Mean Change in % of CD3+CD4+ for Marker CD45RO+(Before treatment to 1 month after therapy initiation)
- Duration of Response (Phase 2)(From response to progression (up to 2 years))
- Mean Change in % of CD3+CD4- for the Marker CD45RO+(Before treatment to 1 month after therapy initiation)
- Mean Change in % of CD3+CD4+ for Marker HLA-DR+(Before treatment to 1 month after therapy initiation)
- Time to Progression (Phase 2)(From registration to progression (up to 2 years))
研究者
研究点 (2)
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