NCT00138164已完成2 期
A Phase II Multicenter Study of Ontak® (Denileukin Diftitox) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective clinical response (complete or partial response)
研究概览
简要总结
RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry cancer-killing substances directly to non-Hodgkin's lymphoma cells.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of denileukin diftitox, in terms of objective response and time to progression, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Secondary
- Determine the safety of this drug in these patients.
- Determine the 1-year 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following subtypes:
- •Diffuse large B-cell lymphoma
- •Follicular lymphoma (grades 1-3)
- •Small lymphocytic lymphoma
- •Transformed B-cell lymphoma
- •Relapsed or refractory disease
- •Disease failed to respond to or progressed after ≥ 2 prior treatment regimens (e.g., high-dose therapy [HDT] with stem cell transplantation [SCT]*) NOTE: *Patients who have received HDT with SCT are considered to have diminished bone marrow reserve
- •Diminished bone marrow reserve AND/OR mild to moderate cytopenia, meeting 1 of the following criteria:
- •Absolute neutrophil count ≥ 1,000/mm^3 but < 1,500/mm^3 (growth factor independent)
- •WBC ≥ 2,000/mm^3 but < 4,000/mm^3 (growth factor independent)
- •Platelet count ≥ 40,000/mm^3 (25,000/mm^3 if thrombocytopenia is secondary to marrow involvement by lymphoma) but < 150,000/mm^3 (platelet transfusion independent)
- •At least 1 bidimensionally measurable lymph node or tumor mass ≥ 4 cm
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 16 weeks
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2 times ULN
- •Albumin ≥ 3.0 g/dL
- •No history of veno-occlusive disease of the liver
- •No chronic hepatitis
- •Creatinine < 2 times ULN
- •Cardiovascular
- •No congestive heart failure
- •No New York Heart Association class III-IV cardiac disease
- •No ventricular tachycardia
- •No fibrillation
- •No myocardial infarction within the past 12 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known HIV positivity
- •No active GVHD ≥ grade 2 within the past 6 months
- •No other serious medical illness or active infection that would preclude study participation
- •No known hypersensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or their excipients)
- •No other malignancy within the past 5 years except successfully treated carcinoma in situ of the cervix or basal cell carcinoma
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •At least 6 months since prior allogeneic SCT
- •No concurrent immunotherapy
- •Chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •No concurrent anticancer hormonal therapy
- •No concurrent corticosteroids for the treatment of NHL
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
Objective clinical response (complete or partial response)
次要结局
- Time to progression
- Overall survival at 1 year
- Safety
研究者
研究点 (1)
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