A Phase II Study of Newly Diagnosed Patients With BCR/ABL (+) Chronic Myelogenous Leukemia Treated With Combined Homoharringtonine (NSC #141633) and Low-Dose Cytarabine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Complete cytogenetic, major cytogenetic, and hematologic response rate
研究概览
简要总结
Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the hematologic and cytogenetic response rate of newly diagnosed patients with BCR/ABL (+) chronic myelogenous leukemia (CML) treated with combined homoharringtonine (omacetaxine mepesuccinate) and low dose cytarabine.
II. To estimate the toxicity of these two drugs given in combination in a cooperative group setting.
SECONDARY OBJECTIVES:
I. To assess duration of hematological response and incidence of hematological progression for all patients.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of chronic myelogenous leukemia (CML) in chronic phase; patients in either accelerated or blastic phases are not eligible; clonal cytogenetic evolution alone does not exclude patients
- •Patients must meet one or more of the following criteria:
- •Cytogenetically determined Philadelphia chromosome (Ph+)
- •BCR/ABL protein detectable by immunoblotting
- •Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL
- •BCR/ABL translocation present by fluorescence in situ hybridization (FISH)
- •Registration within eight weeks of the diagnosis and confirmation of Ph+ or BCR/ABL+ CML
- •No more than eight weeks of prior hydroxyurea therapy
- •No previous therapy with homoharringtonine (HHT)
- •No prior treatment for CML with agents other than hydroxyurea; thus, prior treatment for CML with agents such as interferon, busulfan or cytarabine will render patients ineligible
- •Must not be a candidate for an early allogeneic bone marrow transplant; potential transplant candidates must be counseled about alternative donor transplants and must decline that treatment option
- •ECOG performance status 0-2
- •Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control
- •Bilirubin =< x upper limit of normal
- •Creatinine =< 1.5 mg/dl
排除标准
- 未提供
研究组 & 干预措施
Treatment (omacetaxine mepesuccinate, cytarabine)
Patients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon.
干预措施: omacetaxine mepesuccinate (Drug)
Treatment (omacetaxine mepesuccinate, cytarabine)
Patients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon.
干预措施: cytarabine (Drug)
Treatment (omacetaxine mepesuccinate, cytarabine)
Patients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Complete cytogenetic, major cytogenetic, and hematologic response rate
时间窗: Up to 9 months
Two separate single-stage Fleming designs will be used to test hypotheses regarding the major cytogenetic response rate and the complete cytogenetic response rate. Calculated and presented with their 95% confidence intervals.
次要结局
- Toxicity rates as assessed by Common Terminology Criterial version 2.0(Up to 9 months)
- Duration of hematological response(Up to 10 years)
- Time to hematological progression(Up to 10 years)