NCT00052572已完成2 期
A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed or refractory lymphoproliferative disorders.
详细描述
OBJECTIVES:
Primary
- Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone.
Secondary
- Determine the time to progression and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
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 relapsed/recurrent or refractory indolent lymphoproliferative disorder of 1 of the following types:
- •Chronic lymphocytic leukemia
- •Absolute lymphocytosis greater than 5,000/mm^3
- •B-cell phenotype (CD 19, 20, or 23 positive) with more than 30% bone marrow lymphocytes
- •B-cell small lymphocytic lymphoma
- •Marginal zone B-cell lymphoma
- •Grade I-III follicle center cell lymphoma
- •Waldenstrom's macroglobulinemia
- •Mantle cell lymphoma
- •At least 1 unidimensionally measurable lesion for patients with non-Hodgkin's lymphoma
- •At least 2 cm by conventional techniques
- •No active brain metastases
- •Treated CNS disease allowed
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3 (500/mm^3 if there is lymphomatous involvement of the bone marrow)
- •Platelet count ≥ 50,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST or ALT ≤ 2.5 times ULN (4 times ULN if there is liver involvement)
- •Creatinine ≤ 2 times ULN OR
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •No history of orthostatic hypotension
- •No myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 3 months
- •No New York Heart Association class III or IV congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No uncontrolled hypertension requiring manipulation of antihypertensive medications
- •No evidence of any of the following by echocardiogram:
- •Acute ischemia
- •Significant conduction abnormality
- •Bifascicular block
- •2^nd- or 3^rd-degree atrioventricular block
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No other immunodeficiency
- •No known severe hypersensitivity reaction to agents containing Cremophor EL
- •No ongoing or active infection
- •Febrile episodes up to 38.5° Celsius allowed in the absence of infection
- •No other concurrent uncontrolled illness that would preclude study participation
- •No psychiatric illness or social situation that would preclude study compliance
- •No preexisting grade II or greater sensory neuropathy
- 另有 19 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety
Efficacy
次要结局
- Progression-free survival
- Mean and median duration of response
- Mean and median duration of progression-free and overall survival
- Probability of polymerase chain reaction negativity after treatment
研究者
研究点 (2)
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