International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy.
Secondary
- Determine overall survival.
- Evaluate relapse-free survival for patients achieving complete or partial response.
- Determine the rate of disease progression.
- Determine response rate at the end of study therapy.
- Assess the toxicities of this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed large B-cell lymphoma
- •Stage I, II, III, or IV disease
- •Bone marrow or lymph node involvement by small cell lymphoma allowed
- •No serious, progressive pathology (at investigator's discretion)
- •CD20-positive disease
- •Measurable disease
- •No prior indolent lymphoma, treated or not
- •No meningeal or CNS lymphoma
- •PATIENT CHARACTERISTICS:
- •International prognostic index < 2 (adjusted for age)
- •Life expectancy > 3 months
- •ALT and AST ≤ 2.5 times upper limit of normal
- •Bilirubin ≤ 30 mmol/L
- •Creatinine ≤ 150 μmol/L
- •HIV, hepatitis B virus, and hepatitis C virus negative (unless after vaccine)
- •No contraindication to chemotherapy or immunotherapy
- •No cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •No contraindication to a venous catheter
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 30 days since prior and no other concurrent investigational treatment
- •No prior therapy
- •No concurrent participation in another clinical study
排除标准
- 未提供
研究组 & 干预措施
R-CHOP14 chemotherapy
干预措施: doxorubicin hydrochloride (Drug)
R-CHOP14 chemotherapy
干预措施: cyclophosphamide (Drug)
R-CHOP14 chemotherapy
干预措施: prednisone (Drug)
R-CHOP14 chemotherapy
干预措施: yttrium Y 90 ibritumomab tiuxetan (Radiation)
R-CHOP14 chemotherapy
干预措施: vincristine sulfate (Drug)
R-CHOP14 chemotherapy
干预措施: rituximab (Biological)
结局指标
主要结局
Event-free survival
时间窗: 1 year
次要结局
- Overall survival(up to one year)
- Relapse-free survival in responding patients(up to one year)
- Rate of disease progression(up to 2 years)
- Response rate(up to six months)
- Toxicities(up to 2 years)