Phase I Study of Thrice Weekly Hu1D10*in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Acute Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- MTD defined as the dose level below which two or more of six patients experience a DLT assessed using NCI CTC version 2.0
研究概览
简要总结
Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) or biological effective dose of monoclonal antibody Hu1D10 (apolizumab) in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.
II. Determine the safety of this drug, in terms of frequency and severity of treatment-related adverse events, in this patient population.
SECONDARY OBJECTIVES:
I. Determine whether this drug has anti-leukemia/lymphoma activity in patients expressing the Hu1D10 antigen.
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
- •One of the following diagnoses:
- •Histologically confirmed chronic lymphocytic leukemia (CLL) or non-contiguous stage II or stage III-IV small lymphocytic lymphoma (SLL)
- •Previously treated with at least 1 form of chemotherapy or immunotherapy
- •Histologically confirmed acute lymphoblastic leukemia (enrolled after the maximum tolerated dose (MTD) is determined)
- •Must have failed 1 prior therapy
- •Ineligible for allogeneic stem cell transplantation
- •Histologically confirmed acute myeloid leukemia (enrolled after the MTD is determined)
- •Primary refractory or relapsed (within the past year) disease
- •Ineligible for potential curative therapy
- •Express Hu1D10 antigen
- •Greater than 2 times the mean fluorescence intensity of the control by flow cytometry (blood or bone marrow cells) OR
- •Positive by immunohistochemical staining (lymph node)
- •Presenting with one of the following indications for treatment unless early bone marrow transplantation is planned (CLL or SLL patients only):
- •Disease-related progressive symptoms
- •Progressively worsening anemia or thrombocytopenia
- •Progressively worsening lymphadenopathy
- •Massive splenomegaly or hypersplenism
- •Hyperlymphocytosis (WBC greater than 200,000/mm3) or lymphocyte doubling time less than 12 months
- •Marrow failure secondary to marrow infiltration by leukemia or lymphoma
- •Performance status - ECOG 0-2
- •At least 2 years
- •See Disease Characteristics
- •Platelet count at least 50,000/mm^3 (without transfusion)
- •Bilirubin no greater than 3 mg/dL (unless elevated secondary to tumor)
- •Creatinine no greater than 2.0 mg/dL
- •No prior decompensated congestive heart failure, unstable angina, or myocardial infarction within the past 6 months not corrected by percutaneous transluminal coronary angioplasty or surgery
- •No active infection requiring oral or IV antibiotics
- •No other malignancy that would limit life expectancy
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study
- •See Disease Characteristics
- •At least 1 month since prior rituximab or alemtuzumab (unless CD20 or CD52 antigen is expressed on tumor cells)
- •No prior monoclonal antibody Hu1D10
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
MTD defined as the dose level below which two or more of six patients experience a DLT assessed using NCI CTC version 2.0
时间窗: Up to 30 days
次要结局
- Evaluation of the degree of apoptosis induced by ex vivo incubation of human CLL cells with Hu1D10(Up to 1 year)
- Cytokine release(Up to 1 year)
- Caspase activation(Up to 1 year)
- Signaling and expression of apoptosis protein(Up to 1 year)