A Phase II Trial of AZD2171 in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Confirmed response defined to be an objective status of complete remission [CR], nodular partial remission [nPR], and partial remission [PR]
研究概览
简要总结
This phase II trial is studying how well AZD2171 works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. AZD2171 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer cells
详细描述
OBJECTIVES:
I. Evaluate the response rate in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) treated with AZD2171.
II. Evaluate the toxicity of AZD2171 in patients with relapsed or refractory B-CLL.
III. Evaluate the complete response rate, progression-free and overall survival distributions, and duration of response in patients with relapsed or refractory B-CLL treated with AZD2171.
IV. Assess vascular endothelial growth factor receptor-2 (VEGFR-2) protein and phosphorylation levels in B-CLL cells using pretreatment samples and evaluate the association between Rai stage at study entry and clinical response to AZD2171.
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
- •Histological confirmation of B-cell chronic lymphocytic leukemia (B-CLL)
- •Peripheral blood lymphocyte count > 5,000/mm³
- •Small to moderate peripheral blood lymphocytes with ≤ 55% prolymphocytes
- •Bone marrow aspirate with ≥ 30% lymphoid cells
- •Monoclonality of B lymphocytes by immunophenotyping, demonstrating all of the following:
- •B-cell markers with CD5 antigen in the absence of other pan-T-cell markers (CD3, CD2, etc.)
- •CD19 and/or CD20
- •Expression of CD23 on the CLL cells OR dim B-cell expression of kappa or lambda light chains
- •Disease must be refractory to or progressive after treatment with at least 1 course containing a purine nucleoside analog (e.g., fludarabine, cladribine, or pentostatin)
- •Life expectancy > 6 months
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 50,000/mm³
- •Hemoglobin ≥ 8 g/dL
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Patients with Gilbert's syndrome may have a bilirubin ≥ 1.5 times ULN
- •AST and ALT ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of allergies to compounds similar to AZD2171
- •QTc prolongation < 500 msec
- •No other significant ECG abnormality
- •No history of familial long QT syndrome
- •Proteinuria < 1+ by dipstick OR protein < 1 g/24 hr urine collection
- •No known HIV positivity
- •No New York Heart Association (NYHA) class III or IV disease
- •NYHA class II disease controlled with treatment and monitoring allowed
- •No other uncontrolled illness including, but not limited to, the following:
- •Hypertension
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness or social situations that would limit compliance
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy, anti-vascular endothelial growth factor (VEGF) treatment, or major surgery and recovered
- •More than 30 days since prior investigational agents
- •No concurrent drugs or biologics with proarrhythmic potential
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: cediranib maleate (Drug)
Treatment (cediranib maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Confirmed response defined to be an objective status of complete remission [CR], nodular partial remission [nPR], and partial remission [PR]
时间窗: Up to 5 years
Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
次要结局
- Complete response rate estimated by the number of confirmed complete responses (CR) observed in the trial divided by the total number of evaluable patients(Up to 5 years)
- Overall survival(From the date of registration to the date of death, assessed up to 5 years)
- Time to progression as estimated by Kaplan-Meier method(From the date of registration to the date of disease progression, assessed up to 5 years)
- Duration of response(From the date at which the patient's objective status is first noted to be a response to the date that progression or death is documented, assessed up to 5 years)