A Prospective Cohort of Obinutuzumab and Chlorambucil (GC) Chemotherapy for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Including Next- Generation Sequencing (NGS)-Based Assessment
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
This study is prospective, open-label, single arm observational study to assess efficacy of obinutuzumab plus chlorambucil (GC) chemotherapy in treatment naïve CLL, and prognostic impact of genetic alterations for CLL using NGS.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
- •Newly diagnosed chronic lymphocytic leukemia
- •Age≥ 70 years
- •Satisfy the one of indications for starting treatment guideline
- •Evidence of progressive marrow failure (anemia, thrombocytopenia)
- •AIHA, thrombocytopenia refractory to steroids
- •Massive (>6cm, LCM) or symptomatic splenomegaly
- •Massive nodes (>10 cm) or symptomatic
- •Progressive lymphocytosis
- •50% increase over 2 months or LDT < 6 months
- •Constitutional Symptoms : weight loss > 10% in 6 months, significant fatigue, fever >38 over 2 weeks, night sweat > 1month
- •ECOG performance status 0-2
- •Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
- •Aspartate aminotransferase (AST) ≤ 5 x ULN, (ALT) ≤ 5 x ULN
- •Creatinine ≤ 3.0 x ULN
- •Provide informed consent Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
排除标准
- •Unmet NGS samples by bone marrow biopsy or peripheral bloods at diagnosis
- •Hairy cell leukemia or prolymphocytic leukemia
- •Uncontrolled infection
- •Therapy history with combined chemotherapy or biologic therapy prior to registration
- •History of thromboembolic episodes ≤ 3 months prior to registration
- •Active hepatitis B or C with uncontrolled disease
- •Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
- •Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
- •Concurrent participation in another therapeutic clinical trial.
研究组 & 干预措施
GC chemotherapy
Before administration of GC chemotherapy, all patients must undergo pretreatment bone marrow biopsy. The pretreatment BM biopsy must include at least 1 long core biopsy samples and 10 cc of aspirate.
Obinutuzumab 1000mg fixed dose will be administered intravenously (Day 1,8,15 for cycle 1 and D1 for subsequent cycles). Chlorambucil 0.5mg/kg will be administered orally (D1,15 for all cycles).
28 days are considered as one cycle, and cycles will be repeated every 4-weeks for a total of 6 cycles.
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Overall response rate
时间窗: 3 years
iwCLL criteria
次要结局
- Complete remission rate(3 years)
- Overall survival(3 years)
- Progression free survival(3 years)
研究者
Deok-Hwan Yang
M.D., Ph.D.
Chonnam National University Hospital