NCT00049075已完成2 期
A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 34
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.
详细描述
OBJECTIVES:
- Determine the overall response rate (complete and partial) in patients with previously untreated B-cell chronic lymphocytic leukemia treated with oral fludarabine.
- Determine the molecular complete response rate in patients who achieve a clinical or immunophenotypic complete response when treated with this drug.
- Determine the progression-free and treatment-free survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the baseline incidence of defined genetic abnormalities in patients treated with this drug.
- Determine the prognostic and predictive significance of defined genetic abnormalities in patients with respect to response to treatment with this drug.
- Determine the prognostic and predictive significance of immunophenotypic profile of patients with respect to response to treatment with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral fludarabine on days 1-5. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission after 6 courses do not receive further study therapy.
Patients are followed at 2 months and then every 4 months for 2 years.
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 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)
- •Previously untreated
- •Rai stage I, II, III, or IV
- •Requiring systemic therapy
- •Persistent lymphocytosis of greater than 5,000/mm^3
- •Morphologically mature lymphocytes
- •Monoclonal B-cell population
- •CD19/CD5/CD23 positive with kappa or lambda light chain restriction by immunophenotyping
- •No other lymphoproliferative disorders including prolymphocytic leukemia, mantle cell lymphoma, progression to aggressive B-cell lymphoma, or Richter's syndrome
- •No clinical autoimmune hematologic complication of CLL including Coomb's-positive hemolytic anemia or immune thrombocytopenia
- •Positive Coomb's test allowed if no clinical hemolysis
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST and/or ALT no greater than 2 times ULN
- •Creatinine no greater than 2 times ULN
- •Accessible for treatment and follow-up
- •No known HIV infection
- •No active bacterial, viral, or fungal infection requiring systemic antibiotics
- •No conditions requiring corticosteroid therapy
- •No history of other malignancies except for the following:
- •Adequately treated nonmelanoma skin cancer
- •Curatively treated carcinoma in situ of the cervix
- •Other solid tumors curatively treated with no evidence of disease within the past 5 years
- •No other major medical illness that would preclude study
- •No known hypersensitivity to fludarabine or its components
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy including monoclonal antibody therapy
- •No concurrent autologous or allogeneic stem cell or bone marrow transplantation
- •Chemotherapy
- •No other concurrent cytotoxic drugs
- •Endocrine therapy
- •No concurrent corticosteroids except inhaled or topical corticosteroids
- •No concurrent corticosteroids for nausea prophylaxis
- •Radiotherapy
- •No prior radiotherapy affecting more than 25% of bone marrow and/or involving the pelvic area
- •No concurrent radiotherapy
- •Not specified
- •At least 4 weeks since prior investigational agents
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
研究点 (34)
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