Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Complete Response (CR)
研究概览
简要总结
This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy.
Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.
详细描述
As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
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
- •Patient must have confirmed B-CLL.
- •Patients must have received at least one prior therapy and must require treatment for active disease
排除标准
- •Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc) within 4 weeks of start of study.
- •History of significant allergic reaction to antibody therapies that required discontinuation of antibody therapy
- •History of human immunodeficiency virus (HIV) positivity.
- •Active infection requiring treatment
- •Pregnancy or lactation
- •Other severe, concurrent diseases or mental disorders
- •Central nervous system involvement of chronic lymphocytic leukemia (CLL)
研究组 & 干预措施
Alemtuzumab plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days.
干预措施: Alemtuzumab plus Fludarabine (Drug)
结局指标
主要结局
Complete Response (CR)
时间窗: 28 days after last cycle with confirmation 2 months later
Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes \<30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.
次要结局
- Overall Survival (OS)(1 year after start of treatment)
- Progression-free Survival (PFS)(1 year after start of treatment)
- Percentage of Participants With Overall Response at Different Observation Times(from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier)
- Number of Participants With Minimal Residual Disease (MRD)(When CR is confirmed)
- Overall Response (OR)(28 days after last cycle with confirmation 2 months later)