NCT00440388已完成2 期
An Open-label, Multicenter, Phase II Study of AT-101 in Combination With Rituximab in Patients With Untreated, Grade I-II, Follicular Non-Hodgkin's Lymphoma
Ascenta Therapeutics38 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 38
- 主要终点
- complete or partial remission of disease
研究概览
简要总结
This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.
详细描述
Further Study Details provided by Ascenta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 confirmed, previously untreated Grade I-II follicular B-cell non-Hodgkin's lymphoma (stage I, II, III and IV). Patients may have received radiation therapy to one lymph node region; Stage I or II patients must have relapsed after prior radiation therapy to be eligible;
- •Patients with any FLIPI score may participate. Patients with FLIPI scores 3-5 may be enrolled with asymptomatic disease, or without worsening disease or disease related-symptoms; however patients with FLIPI scores of 0-2 must have evidence of worsening disease;
- •ECOG performance status 0-1;
- •Measurable disease;
- •Adequate hematological function as indicated by:
- •Absolute neutrophil count (ANC) >1,000/µL; +Hemoglobin >8 g/dL (It is acceptable to transfuse PRBC to achieve this criterion);
- •Platelet count >50 x 109/L.
- •Adequate hepatic and renal function as indicated by:
- •Serum creatinine ≤2.0 mg/dL;
- •Serum albumin ≥2.5 g/dL;
- •Total bilirubin ≤1.5 x upper limit of normal (ULN);
- •Serum AST and ALT ≤1.5 x ULN.
- •Able to swallow and retain oral medication
排除标准
- •Patients who have severe lymphoma-related symptoms requiring a rapid response to therapy (e.g., requirement for cytoreduction due to advanced disease or organ compromise, respiratory compromise because of large effusions or airway obstruction, bowel obstruction, ureteral obstruction, and chylous ascites);
- •Active symptomatic fungal, bacterial and/or viral infection including, but not limited to active HIV or viral hepatitis (A, B or C);
- •History of hepatitis B infection;
- •Any B-cell, T-cell or transformed lymphoma other than histologically confirmed follicular non-Hodgkin's lymphoma;
- •Central nervous system (CNS) lymphoma, CNS or leptomeningeal involvement by lymphoma (treated or in remission), HIV-related lymphoma, or patients with symptoms suggesting HIV infection;
结局指标
主要结局
complete or partial remission of disease
时间窗: 8 weeks
次要结局
- duration of complete or partial remission of disease(10 months)
- number of participants with adverse events(10 months)
研究者
研究点 (38)
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