NCT00082940已完成2 期
A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 11
研究概览
简要总结
RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth of cancer cells and slow the growth of chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox.
Secondary
- Determine the toxicity profile of this drug in these patients.
- Determine the response rate in patients (regardless of CD25 receptor density) treated with this drug.
- Determine the progression-free survival and overall survival of 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria at any time during the course of disease (e.g., at initial diagnosis or relapse):
- •Absolute lymphocytosis > 5,000/mm^3
- •Lymphocytes must appear mature with < 55% prolymphocytes
- •More than 30% of all nucleated cells are lymphoid on bone marrow aspirate smear
- •Lymphoid infiltrates compatible with bone marrow involvement by CLL on core bone marrow biopsy
- •Predominant B-cell monoclonal population of cells share the B-cell marker (CD19) with the CD5 antigen in the absence of other pan-T-cell markers by lymphocyte immunophenotyping
- •High-risk disease OR intermediate-risk disease
- •Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least 1 of the following criteria:
- •Massive or progressive splenomegaly and/or adenopathy
- •Weight loss > 10% within the past 6 months
- •Common toxicity grade 2-4 fatigue
- •Fevers > 100.5°F OR night sweats for more than 2 weeks without evidence of infection
- •Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months
- •Failed at least 1 prior fludarabine regimen, as defined by 1 of the following criteria:
- •Refractory or intolerant to fludarabine
- •Relapsed within 6 months after completion of fludarabine
- •No CNS leukemia
- •No mantle cell lymphoma in leukemic phase
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-2
- •Life expectancy
- •More than 2 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 50,000/mm^3
- •Hemoglobin ≥ 8 g/dL (transfusion allowed)
- •Albumin ≥ 3 g/dL
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •No hepatitis B or C infection
- •Creatinine ≤ 1.5 mg/dL OR
- •Creatinine clearance ≥ 40 mL/min
- •Cardiovascular
- •LVEF ≥ 40%
- •No uncontrolled infection
- •No other concurrent serious illness
- •No HIV infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use two effective methods of contraception (one must be non-hormonal) during and for at least 1 month after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior denileukin diftitox allowed
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •No concurrent corticosteroids as anti-emetics
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (11)
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