NCT00100711终止2 期
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With Refractory or Relapsed Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- Complete and partial response rates
研究概览
简要总结
The primary purpose of this study is to determine if motexafin gadolinium may be an effective treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Secondly, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening will be evaluated. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •≥ 18 years old
- •CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following: 1) Refractory disease- progressive disease while on therapy, or 2) Relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization
- •ECOG performance status score of 0, 1, or 2
- •Willing and able to provide written informed consent
排除标准
- •Laboratory Values of:
- •Platelet count < 30,000/µL
- •AST or ALT > 2 x ULN (upper limit of normal)
- •Total bilirubin > 2 x ULN
- •Creatinine > 2.0 mg/dL
- •Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
- •Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
- •Uncontrolled hypertension
- •Known history of porphyria (testing not required at screening)
- •Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
- •Known history of HIV infection (testing not required at screening)
- •Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
- •Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection
- •Physical or mental condition that makes patient unable to complete specified follow-up assessments
结局指标
主要结局
Complete and partial response rates
次要结局
- Progression-free survival
- Duration of response
- Safety and tolerability
研究者
研究点 (6)
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