Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- Lenalidomide Maximum Tolerated Dose
研究概览
简要总结
The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.
详细描述
This is a non-randomized, multicenter, open-label, single-arm Phase I/II study in patients with previously untreated CD20-positive CLL. Phase I of the study will evaluate the maximal tolerated lenalidomide dose level in combination with fludarabine/rituximab chemoimmunotherapy in 10 patients. Phase II will determine efficacy using the combination in the previously defined maximal tolerated dose. Both phases will be followed by a maintenance phase evaluating the tolerability and possibility to further improve response quality.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •B-CLL (CD23+, CD5+, CD19+, CD20+)
- •Treatment indication according to NCI criteria
- •Age >= 18 yrs
- •No previous treatment of CLL by chemo-, radio- or immunotherapy
- •Life expectancy > 6 months
- •Written informed consent
- •Women of non-childbearing potential or women of childbearing potential and men using effective contraception
排除标准
- •Active bacterial, viral or fungal infection
- •Positivity for HIV, Hepatitis B or C
- •Reduce organ functions and bone marrow dysfunction not due to CLL
- •Creatinine clearance below 30 ml/min
- •Patients with medical conditions requiring long-term use of systemic corticosteroids during study treatment
- •Patients with a history of severe cardiac disease
- •Other known co-morbidity with the potential to dominate survival
- •Transformation to aggressive B-cell malignancy
- •Known hypersensitivity to humanised monoclonal antibodies or any of the study drugs
- •Pregnant or breast-feeding women
- •Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
研究组 & 干预措施
Treatment Arm
Lenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy
干预措施: Lenalidomide (Drug)
Treatment Arm
Lenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy
干预措施: Fludarabine (Drug)
Treatment Arm
Lenalidomide Dose Escalation combined with Fludarabine/Rituximab followed by maximum tolerated lenalidomide dose/Rituximab maintenance therapy
干预措施: Rituximab (Biological)
结局指标
主要结局
Lenalidomide Maximum Tolerated Dose
时间窗: Dose escalation stage
次要结局
- Response rate for Lenalidomide/Fludarabine/Rituximab combination treatment(Dose escalation stage)
- Safety profile of Lenalidomide/Fludarabine/Rituximab treatment(Study Duration)
- Safety Profile of Lenalidomide/Rituximab(Study duration)
- Response rate for Lenalidomide/Rituximab combination therapy(Study Duration)
- Response rate by 4-colour flow cytometric MRD analysis(Study Duration)
- Changes in Quality of Life scores(Study Duration)
- Risk factors and clonal evolution(Study Duration)