A PHASE II STUDY OF FLAVOPIRIDOL (NSC # 649890) IN PATIENTS WITH PREVIOUSLY TREATED BCELL CHRONIC LYMPHOCYTIC LEUKEMIA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Complete + partial response rate
研究概览
简要总结
Phase II trial to study the effectiveness of flavopiridol in treating patients who have chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
详细描述
OBJECTIVES: Determine the complete and partial response rate to flavopiridol in patients with fludarabine-refractory chronic lymphocytic leukemia.
Assess the toxicity profile of this treatment in these patients. Examine progression-free survival and overall survival following this treatment in these patients.
Determine the effects of flavopiridol on normal T-cell subsets and immunoglobulin levels in these patients.
OUTLINE: This is an open label, multicenter study.
Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable 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
- •Histologically diagnosed intermediate risk (stage I or II) or high risk (stage III or IV) refractory B-cell chronic lymphocytic leukemia
- •Intermediate risk group must have evidence of active disease as shown by at least one of the following:
- •Massive or progressive splenomegaly and/or lymphadenopathy
- •Weight loss of greater than 10% in the last 6 months
- •CALGB grade 2-4 fatigue
- •Fevers greater than 100.5 degree Fahrenheit OR night sweats for greater than2 weeks without evidence of infection
- •Progressive lymphocytosis with an increase greater than 50% over a 2 month period or an anticipated doubling time of less than 6 months
- •Refractory to fludarabine treatment OR relapsed within 6 months of fludarabine
- •Lymphocytosis greater than 5000/mm3 at some time during disease
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No more than 1 prior nonradiolabeled antibody treatment (e.g., Campath-1H or rituximab)
- •At least 1, but no more than 3, prior chemotherapy regimens
- •At least 1 prior chemotherapy regimen comprising fludarabine
- •No other concurrent chemotherapy
- •No concurrent chronic use of oral corticosteroids
- •No concurrent hormone therapy except for non-disease related conditions
- •No concurrent dexamethasone or other corticosteroid-based antiemetics
- •No concurrent palliative radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (flavopiridol)
Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity.
Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3. Treatment repeats every 3 weeks for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: alvocidib (Drug)
Treatment (flavopiridol)
Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity.
Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3. Treatment repeats every 3 weeks for a total of 8 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
Complete + partial response rate
时间窗: Up to 5 years
The CR + PR rate will be estimated with a 95% confidence interval, and the success of the study will be judged with the two-stage design given above.
次要结局
- Toxicity profile of flavopiridol(Up to 5 years)
- Progression-free survival(From onstudy date to the date of progression or death, assessed up to 5 years)
- Overall survival(From onstudy date to the date of death, assessed up to 5 years)