Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Clinical Toxicity
研究概览
简要总结
RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody 4G7xH22 in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
- Assess the clinical toxicity of this antibody in these patients.
OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22.
Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia
- •Primary refractory or multiply relapsed (after at least 2 prior chemotherapy regimens) disease
- •Ineligible for bone marrow or peripheral blood stem cell transplantation
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC greater than 3,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Absolute neutrophil count greater than 1,500/mm^3
- •Bilirubin less than 1.5 mg/dL
- •Alkaline phosphatase less than 2 times normal
- •SGPT less than 2 times normal
- •Creatinine clearance greater than 50 mL/min
- •No human-anti-murine-antibody response to prior murine monoclonal antibodies
- •No immunological or inflammatory disease (e.g., lupus erythematosus)
- •No active serious infection
- •No other serious medical condition that would limit survival to less than 2 years
- •No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
- •No psychiatric or addictive disorder that would preclude study
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior immunotherapy allowed
- •Chemotherapy:
- •See Disease Characteristics
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Concurrent steroids for adrenal failure or adverse reactions to study drug allowed
- •Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Single arm
Antibody
干预措施: bispecific antibody 4G7xH22 (Biological)
Single arm
Antibody
干预措施: sargramostim (Biological)
结局指标
主要结局
Clinical Toxicity
时间窗: day 1-29
This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22
时间窗: Day 1-29
This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
次要结局
- Serum Markers of Macrophage Activation(Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24)