NCT00234026已完成2 期
Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Gemcitabine for the Treatment of Patients With Newly Diagnosed, Relapsed or Chemotherapy Resistant Mantle Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 29
- 主要终点
- Objective response at end of study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of gemcitabine, in terms of objective response and tolerability, in patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.
Secondary
- Determine the time to progression and time to treatment failure in patients treated with this drug.
- Determine the response duration in patients treated with this drug.
- Determine the adverse reactions in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 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:
- •Histologically confirmed mantle cell lymphoma meeting 1 of the following criteria:
- •Newly diagnosed
- •Chemotherapy resistant
- •Relapsed disease after no more than 2 prior lines of chemotherapy
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 11 mm by CT scan
- •No prior or current CNS lymphoma or lymphomatous meningosis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Neutrophil count ≥ 1,500/mm^3 (1,000/mm^3 in case of bone marrow infiltration)
- •Platelet count ≥ 100,000/mm^3 (75,000/mm^3 in case of bone marrow infiltration)
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2 times ULN
- •AST and ALT ≤ 2 times ULN
- •No active hepatitis
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •No congestive heart failure
- •No New York Heart Association class III or IV heart disease
- •No unstable angina pectoris
- •No significant cardiac arrhythmia or arrhythmia requiring chronic treatment
- •No myocardial infarction within the past 3 months
- •Immunologic
- •No active autoimmune disease
- •No ongoing infection (e.g., HIV)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 12 months after study participation
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- •No uncontrolled diabetes mellitus
- •No gastric ulcers
- •No other uncontrolled medical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent thalidomide
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Prior radiotherapy allowed provided indicator lesions were not in the irradiated field
- •No concurrent radiotherapy to the lungs or mediastinum
- •Not specified
- •More than 30 days since prior systemic anticancer treatment
- •More than 30 days since prior clinical trial participation
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective response at end of study treatment
次要结局
- Adverse reactions at end of study treatment
- Time to progression
- Time to treatment failure at end of study treatment
- Response duration
研究者
研究点 (29)
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