A Phase II Study of Sunitinib Malate for Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart
研究概览
简要总结
This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Sunitinib 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.
详细描述
PRIMARY OBJECTIVES:
I. Assess the response rate (complete response [CR] and partial response) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with sunitinib malate.
II. Assess the toxicity of this drug in these patients. III. Assess duration of response, time to progression, overall survival, and CR rate in patients treated with this drug.
SECONDARY OBJECTIVES:
I. Evaluate if known risk stratification parameters (i.e., immunoglobulin mutational status, ZAP-70 status, fluorescent in situ hybridization [FISH] defects, and/or CD38 status) are related to clinical response to sunitinib malate.
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
- •Diagnosis of 1 of the following:
- •Biopsy proven small lymphocytic lymphoma (SLL)
- •Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:
- •Peripheral blood lymphocyte count > 5,000/mm^3
- •Lymphocytes must consist of small to moderate size lymphocytes, with < 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
- •Immunophenotyping consistent with CLL, defined by the following criteria:
- •Predominant population of lymphocytes share both B-cell antigens (i.e., CD19, CD20, or CD23) as well as CD5 in the absence of other pan-T-cell markers (e.g., CD3 or CD2)
- •Dim surface immunoglobulin expression
- •Exclusively kappa and lambda light chains
- •Splenomegaly, hepatomegaly, or lymphadenopathy are not required
- •Refractory or relapsed disease as evidenced by 1 of the following criteria:
- •Progression after ≥ 1 course of a purine nucleoside (i.e., fludarabine phosphate, cladribine, pentostatin) regimen
- •Progression after ≥ 1 course of an alkylator (i.e., cyclophosphamide or chlorambucil) regimen
- •Relapse after ≥ 1 prior purine nucleoside oral kylator (i.e., cyclophosphamide or chlorambucil) regimen
- •Requires chemotherapy, as indicated by any of the following criteria:
- •Measurable (i.e., > 5,000/mm^3) and progressive clonal lymphocytosis
- •Measurable (i.e., single diameter > 2 cm) and progressive lymphadenopathy
- •Disease-related symptoms, including 1 or more of the following:
- •Weight loss > 10% within the past 6 months
- •Extreme fatigue attributed to CLL/SLL
- •Fevers > 100.5^oF for 2 weeks without evidence of infection
- •Night sweats without evidence of infection
- •Evidence of progressive marrow failure, as manifested by the development of or worsening anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelet count < 100,000/mm^3)
- •Massive (i.e. > 6 cm below left costal margin) or progressives plenomegaly
- •No mantle cell lymphoma, as demonstrated by a negative fluorescent in situ hybridization (FISH) analysis fort(11;14)(IgVH/CCND1) on peripheral blood or tissue biopsy
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 months
- •Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
- •AST and ALT ≤ 2.5 times ULN
- •Bilirubin normal
- •Alkaline phosphatase ≤ 3 times ULN
- •Platelet count > 30,000/mm^3 (without transfusion)
- •Absolute neutrophil count > 1,000/mm^3
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to complete patient diaries alone or with assistance
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
- •No other malignancy except for squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless the tumor was curatively treated within the past 2 years
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
- •No inability to swallow or retain sunitinib malate capsules due to any of the following:
- •Gastrointestinal tract disease
- •Requirement for IV alimentation
- •Prior surgical procedures affecting absorption
- •Active peptic ulcer disease
- •No pre-existing thyroid abnormality that would make the patient unable to maintain normal thyroid function with medication
- •No pulmonary embolism within the past 12 months
- •No serious or nonhealing wound, ulcer, or bone fracture
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infections
- 另有 62 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
Arm I
Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
Arm I
Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 28 days for up to 12 courses 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
Number of Participants With a Confirmed Response [Complete Response (CR) and Partial Response (PR)] on 2 Consecutive Evaluations at Least 4 Weeks Apart
时间窗: Duration of Treatment (up to 12 cycles)
National Cancer Institute working group criteria (NCIWG) was used to assess response.\> * CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy\> * PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, \>100000/μL platelets, \>11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions
次要结局
- Survival Time(Duration of study (up to 2 years))
- Progression-free Survival(Duration of study (up to 2 years))
- Complete Response Rate in Patients With B-cell Chronic Lymphocytic Leukemia(Duration of Treatment (up to 12 cycles))
- Duration of Response(Duration on study (up 2 years))