NCT00385125Unknown2 期
Phase II Study for Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL and Anthracycline Chemotherapy Pretreatment, Who Received or Did Not Qualify for Autologous Stem Cell Transplantation.
University of Magdeburg2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- response duration
研究概览
简要总结
Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation.
详细描述
Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation. Aim is to find response rates and duration of combination chemotherapy (bendamustine/rituximab) in patients with relapsed or refractory CD 20 positive B cell NHL.
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 proven high grade B-NHL (CD 20 >= 20 % positive)
- •Age >= 18 years
- •At least one pretreatment with anthracycline polychemotherapy +/- radiatio:
- •first relapse nad contraindication for aggressive salvage therapy e.g. high dose therapy with autologous stem cell transplantation
- •second relapse (after aggressive salvage therapy)
- •patient's refusal of aggressive salvage therapy in first relapse
- •informed consent
排除标准
- •untreated patients
- •pretreatment with bendamustine
- •primary CNS- lymphoma
- •Karnofsky index < 50 (except caused by lymphoma)
- •HIV positive, hepatitis B or C
- •serious concurrent disease
- •non-compensated heart failure (>=NYHA 3)
- •non-compensated hypertension
- •renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma
- •hepatic insufficiency with transaminase values greater than 3-fold of normal values and/or bilirubin levels > 200 µmol/l, not related to lymphoma
- •missing compliance respective incapability to comply (e.g.cerebral dysfunction
- •pregnancy
- •hematopoetic insufficiency not lymphoma related (leucocyte count <= 2500/µl, granulocyte count <= 1000/µl, platelet count <= 80000/µl)
结局指标
主要结局
response duration
response rate
次要结局
- overall survival
- toxicity
研究者
研究点 (2)
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