NCT00694590已完成1 期
Phase I Study of AMD3100 and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Genzyme, a Sanofi Company3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- The maximum tolerated dose of plerixafor when combined with rituximab as treatment for previously treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
研究概览
简要总结
The purpose of this research study is to determine if plerixafor can make CLL/SLL (Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma) cells more sensitive to being killed by rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study, plerixafor will be added to standard treatment with rituximab. Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia.
The primary objective is to determine the maximum tolerated dose (MTD) of plerixafor when combined with rituximab as treatment for previously treated patients with CLL or SLL.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period or be surgically sterile. Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during treatment and for 3 months after the treatment period or be surgically sterile.
- •Diagnosis of CLL or SLL, relapsed from at least one prior therapy.
- •CLL/SLL cells expressing CD20 documented during screening.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Life expectancy of at least 12 weeks.
- •Serum creatinine ≤2.0 mg/dL.
- •Total bilirubin ≤2.0 mg/dL.
- •ALT (alanine aminotransferase) and AST (aspartate aminotransaminase) ≤2 times the upper limit of normal (ULN); for patients with liver involvement of CLL/SLL disease, this limit is increased to ≤5 times the ULN.
- •At the time of enrollment, patients must be >4 weeks since major surgery, radiotherapy, chemotherapy (>6 weeks for some chemotherapies), immunotherapy, biotherapy/targeted or investigational therapies and recovered from the toxicity of prior treatment to ≤ grade 1.
排除标准
- •White Blood Cells (WBC) >250 x 10^9 cells/L.
- •Disease refractory to rituximab therapy- defined as a failure to respond to prior rituximab-containing regimen.
- •Women who are breastfeeding.
- •Active viral hepatitis.
- •Active infection or treatment with antimicrobial or antiviral therapy within 1 week of enrollment with the exception of prophylactic therapy.
- •History of prior allergic reaction to plerixafor or rituximab.
- •Significant lung disease.
- •Serious cardiac disease such as a history of sustained ventricular arrhythmia, uncontrolled and serious congestive heart failure (CHF), angina, acute coronary syndrome, or myocardial infarction within 6 months of enrollment or other significant medical or psychosocial conditions that warrants exclusion.
研究组 & 干预措施
plerixafor
Experimental
干预措施: plerixafor (Drug)
结局指标
主要结局
The maximum tolerated dose of plerixafor when combined with rituximab as treatment for previously treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
时间窗: 29 Days
次要结局
- Area under the concentration-time curve over the dosing interval (τ) (AUC 0-τ) when plerixafor is combined with rituximab(Course 1 (4 weeks))
- The principal toxicities and dose limiting toxicities of plerixafor when combined with rituximab(73 days)
- Area under the concentration-time curve from time zero to the last observed concentration (AUC 0-last) when plerixafor is combined with rituximab(Course 1 (4 weeks)])
- Half-life (T½) when plerixafor is combined with rituximab(Course 1 (4 weeks))
- Time to maximal plasma concentration (Tmax) when plerixafor is combined with rituximab(Course 1 (4 weeks))
- Area under the concentration-time curve from time zero to infinity (AUC 0-∞ ) when plerixafor is combined with rituximab(Course 1 (4 weeks))
- Volume of distribution (Vz/F for subcutaneous (SC) administration; Vz for intravenous (IV) administration);(Course 1 (4 weeks))
研究者
研究点 (3)
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