CHAIROS - Effect of Early Brief Intensification by Chemoimmunotherapy With FCR Followed by FR and Rituximab Maintenance on Clinical Response in Chemo-naïve Patients With B-CLL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 8
- 主要终点
- Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)
研究概览
简要总结
This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.
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
- •Adult patients, >/= 18 years of age
- •B-cell CLL
- •No previous chemotherapy, radiotherapy, or immunotherapy
排除标准
- •Reduced organ function, or bone marrow dysfunction not due to CLL
- •Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer
- •Patients with a history of severe cardiac disease.
研究组 & 干预措施
MabThera/Rituxan
干预措施: rituximab [MabThera/Rituxan] (Drug)
MabThera/Rituxan
干预措施: fludarabine (Drug)
MabThera/Rituxan
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)
时间窗: Weeks 1, 5, 9, 12, 13, 17, 21 and 24
Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (\>)1500 per microliter (/µL), platelets (PL) \>100,000/µL, hemoglobin (Hb) \>11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) \<4000/µL, bone marrow (BM) sample must be normocellular for age, \<30% LC.
次要结局
- Time to Next Treatment - Percentage of Participants With an Event(Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months)
- Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)(Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose))
- Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)(Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose))
- Time to Next Treatment - Time to Event(Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months)
- Percentage of Participants With Adverse Events (AEs)(Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.)