A Phase I/II Study of Daily Oral Polyphenon E in Asymptomatic, Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 73
- 试验地点
- 2
- 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
RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers.
PURPOSE: This phase I/II trial is studying the side effects and best dose of green tea extract and to see how well it works in treating patients with stage 0, stage I, or stage II chronic lymphocytic leukemia (CLL).
详细描述
OBJECTIVES:
Phase I
- Determine the maximally tolerated dose of green tea extract (Polyphenon E) in patients with previously untreated stage 0-II chronic lymphocytic leukemia.
- Describe the dose-limiting toxicity of green tea extract (Polyphenon E).
Phase II
- Evaluate the response rate and response duration of patients with previously untreated, asymptomatic Rai stage 0-II chronic lymphocytic leukemia treated with green tea extract (Polyphenon E) for 6 months at the MTD.
- Further characterize toxicity.
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
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of chronic lymphocytic leukemia (CLL)
- •Stage 0, I, or II disease
- •Previously untreated disease
- •Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
- •Absolute lymphocyte count > 10,000/mm^3
- •Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
- •Phenotypically characterized B-CLL defined by all of the following criteria:
- •A population of leukemic cells that co-expresses the B-cell antigen CD23 as well as CD5 in the absence of other T-cell markers (CD3, CD2, etc.)
- •Dim surface immunoglobulin expression
- •Exclusively κ or λ light chains
- •Mantle cell lymphoma must be excluded by demonstrating the absence of the t(11:14) by FISH testing
- •Patients who require chemotherapy for treatment of CLL, based on any of the following criteria, are excluded:
- •CLL-related symptoms requiring treatment, including any of the following:
- •Unintentional weight loss ≥ 10% body weight within the previous 6 months
- •Extreme fatigue
- •Fevers > 100.5°F for 2 weeks without evidence of infection
- •Night sweats without evidence of infection
- •Evidence of progressive marrow failure due to CLL involvement of bone marrow as manifested by the development of worsening anemia (hemoglobin < 11 g/dl) and/or thrombocytopenia (platelet count < 100,000/mm^3)
- •Thrombocytopenia due to immune phenomena (ITP) is permitted as long as platelet count is ≥ 100,000/mm^3and the patient is not on active pharmacologic therapy
- •Massive (i.e. > 6 cm below left costal margin) or progressive splenomegaly
- •Massive nodes or clusters (i.e., > 10 cm in longest diameter) or progressive adenopathy
- •Progressive lymphocytosis with an increase of > 50% over 2 month period, or an anticipated lymphocyte doubling time of < 6 months
- •PATIENT CHARACTERISTICS:
- •Platelet count ≥ 100,000/µL
- •ANC ≥ 1500/µL
- •Hemoglobin ≥ 11 g/dL
- •Total or direct bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •AST (SGOT) and ALT (SGPT) ≤ 2 x ULN
- •Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 40 mL/min
- •May have a history of autoimmune hemolytic anemia (AIHA) and positive Coombs test provided there has not been active hemolysis requiring transfusion or steroid treatment ≤ 10 weeks prior to registration
- •ECOG performance status 0, 1, or 2
- •Life expectancy of ≥ 6 months
- •No uncontrolled infection
- •No myocardial infarction within the past 6 weeks
- •No New York Heart Association class III or IV congestive heart failure
- •Not pregnant or nursing
- •Negative pregnancy test
- •Must employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) prior to study entry and for the duration of study participation
- •No other severe medical or psychiatric illness
- •No active hemolysis requiring transfusion or other pharmacologic therapy
- •PRIOR CONCURRENT THERAPY:
- •At least 8 weeks since prior and no other concurrent over the counter green tea or green tea extract
- •No prior daily use of over the counter green tea products for medicinal purposes for > 4 weeks (phase II only)
- •No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
- •No concurrent combination anti-retroviral therapy for HIV positive patients
- •No concurrent oral steroid preparations
排除标准
- 未提供
研究组 & 干预措施
polyphenon E
Designed to assess toxicity, treatment response, and pertinent laboratory measurements in patients with previously untreated, asymptomatic, Rai Stage 0-II CLL.
干预措施: Polyphenon E (Biological)
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: 6 months
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
Number of Participants With Biological Response (Bio-R) on 2 Consecutive Evaluations at Least 4 Weeks Apart
时间窗: 6 months
Bio-R: A reduction in the absolute lymphocyte count (ALC) of more than 20% from the pretreatment level for at least 2 months or a \>= 30% reduction in all palpable lymphadenopathy without meeting the NCIWG criteria for PR was required
次要结局
- Number of Participants With a Confirmed Complete Response (CR)(6 months)