Phase II Study of 90Y-ibritumomab Tiuxetan Treatment as a Consolidation After 6th R-CHOP Chemotherapy in Patients With Limited-stage, Bulky Diffuse Large B Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response
研究概览
简要总结
This phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL).
详细描述
The patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL) are known to have a poor prognosis as like to those with advanced disease. However, there are very limited studies to compare the clinical outcome of therapy after chemotherapy only with combined modality using radiation. Defining local failure at bulky sites as one component of relapse, radioimmuotherapy appears to reduce the failure rates at previous bulky sites. We assessed the clinical efficacy and toxicity of 6th R-CHOP chemotherapy and followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky DLBCL.
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
- •Newly diagnosed CD20+ DLBCL
- •Patients with stage I/II
- •Bulky disease defined by maximum diameter greater than 10 cm or any mediastinal mass exceeding 1/3 the maximum trans- thoracic diameter (more than 8 cm)
- •Patients that achieved a complete (CR) or partial response (PR) after 6th R-CHOP chemotherapy
- •Aged over 18 years
- •ECOG performance status 0-2.
排除标准
- •Previous history of chemotherapy for diffuse large B cell lymphoma
- •Prior myeloablative therapy
- •Prior external-beam radiation to >25% of active bone marrow
- •Pregnancy and lactation
- •>25% bone marrow infiltration
- •Platelet counts <100 000/µl, neutrophil counts <1500/µl
- •Children and adolescents under 18 years of age
- •Presence of CNS involvement with diffuse large B cell lymphoma
- •Positive HIV serology
- •Seriously uncontrolled, current infections or other concomitant
研究组 & 干预措施
ibritumomab tuixetan, response, toxicity
干预措施: ibritumomab tiuxetan (Zevalin) (Drug)
结局指标
主要结局
Objective response
时间窗: Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan
Patients receive six cycles of R-CHOP chemotherapy per 21-day intervals. Patients with clearly documented progressive disease will be taken off the study when progression is noted. Patients who achieved a complete or partial response after 6th R-CHOP chemotherapy will receive ibritumomab tiuxetan treatment as a consolidation.
Safety and toxicity
时间窗: 3 years after the infusion of 90Y-ibritumomab tiuxetan
After Zevalin treatment, safety profiles will be evaluated with physical examination, vital signs, performance status, serum chemistry and electrolytes, and lymphocytes subset using NCI Common Terminology Criteria for Adverse Events version 3.0, every 4 weeks for 6 months, and then every 3 months for the next 6 months.
次要结局
- Progression-free survival(the time from start of R-CHOP to the first recording of disease progression or death of any cause)